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OCATA THERAPEUTICS, INC. Message Board

beareclawe 469 posts  |  Last Activity: 4 hours ago Member since: Jan 10, 2011
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  • Reply to

    A Lot of Uncertainty But One Thing Is Certain

    by hschlauch Feb 11, 2015 7:33 PM
    beareclawe beareclawe May 10, 2015 8:45 AM Flag

    Re: On a long-term basis, we have no expectation of generating any meaningful revenues from our product candidates for a substantial period of time and must rely on raising funds in capital transactions to finance our research and development programs.

    Yep

    : )

  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe May 10, 2015 8:58 AM Flag

    Re: Maxim? Hold!!!
    dsroyal91 Sentiment: Strong Buy

    Jason Kolbert, an analyst with Maxim Group, cited Ocata’s funding risk in a March report to clients, saying the company needs “funding for the trials and trial data to attract the funding.”

    Citation:

    By Lisa Eckelbecker
    TELEGRAM & GAZETTE STAFF
    May 04. 2015 4:42PM
    Ocata reports positive transplants in Korean patients

    MARLBORO – More patients have been safely treated for vision disorders with eye cells created by Ocata Therapeutics Inc., the biotechnology company said.

    Ocata said four additional patients have received transplants of the retinal pigment epithelial cells, bringing the total number of patients treated with the cells to 42.

    The most recent findings, which focused on four patients in Asia, were reported last week in the online journal Stem Cell Reports.

    Ocata, previously known as Advanced Cell Technology, is developing medical treatments generated from human embryonic stem cells. It is testing retinal cells as a possible treatment for two disorders that destroy vision, age-related macular degeneration and Stargardt’s macular degeneration.

    In the most recent study, Korean researchers transplanted cells into four Asian patients’ eyes and checked up on them for a year. The patients safely tolerated the transplants, the researchers said.

    “I think it’s exciting that a group on the other side of the planet was able to independently confirm the potential safety and efficacy of pluripotent stem cells,” said Dr. Robert P. Lanza, Ocata chief scientific officer. “Together with our results here in the U.S., I think this bodes well for the future of stem cell therapies.”

    Under Chief Executive Paul K. Wotton, Ocata has launched its new name and completed a reverse-stock split while pushing forward with its research. The company’s stock, which had traded on over-the-counter electronic exchanges, was recently accepted for trading on the Nasdaq Global Market.

    Yet with no products on the market, Ocata brings in almost no revenue. It posted a loss of $36.6 million during 2014, after paying dividend to holders of preferred stock shares, and ended 2014 with a $4.4 million cash cushion. The company withdrew plans for a stock offering in February.

    Jason Kolbert, an analyst with Maxim Group, cited Ocata’s funding risk in a March report to clients, saying the company needs “funding for the trials and trial data to attract the funding.”

    Ocata officials have reported plans to begin the second phase of testing RPE cells in humans this year.

    : )

  • Reply to

    Maxim?

    by dsroyal91 Mar 14, 2015 3:42 PM
    beareclawe beareclawe May 10, 2015 10:10 AM Flag

    Re: Yet with no products on the market, Ocata brings in almost no revenue. It posted a loss of $36.6 million during 2014, after paying dividend to holders of preferred stock shares, and ended 2014 with a $4.4 million cash cushion. The company withdrew plans for a stock offering in February.

    05/07/15 10-Q
    Cash Flows from Financing Activities
    (excerpt)
    As of March 31, 2015, we have $3,532,602 in cash. As of March 31, 2015, $12,498,749 is available to us through the Lincoln Park financing arrangement. On various dates from April 1, 2015 through May 7, 2015, Lincoln Park purchased 280,892 shares of common stock for cash proceeds to the Company of $1,904,816. As of May 7, 2015, the Company has $10,593,933 available to us through the Lincoln Park financing arrangement.

    We have no expectation of generating any meaningful revenues from our product candidates for a substantial period of time and must rely on raising funds in capital transactions to finance our research and development programs. Our future cash requirements will depend on many factors, including the pace and scope of our research and development programs, the costs involved in filing, prosecuting and enforcing patents, and other costs associated with commercializing our potential products.

    We believe that our current cash balance, and the $12,498,749 available to us under the Lincoln Park financing arrangement as of March 31, 2015, will be sufficient to fund our operations into early 2016. This belief is based on the assumption that our stock price does not realize any significant or prolonged decreases. Our ability to fund our operations through the Lincoln Park arrangement is highly dependent on our stock price. A significant decline in our share price could force us to curtail our operations in part, or entirely. We are continually in discussions with potential investors and collaborators to explore alternative sources of funding which may or may not result in immediate and substantial dilution to our stockholders, so that we may either extend our current cash runway beyond early 2016 or accelerate the rate of investment in our many clinical and pre-clinical programs.



    We cannot assure you that public or private financing or grants will be available on acceptable terms, if at all. Several factors will affect our ability to raise additional funding, including, but not limited to, the volatility of our common stock and the broader public equity market, especially public equities issued by other pre-commercial biotechnology companies, and our ability to raise capital through non-dilutive transactions such as out-licenses. If we are unable to raise additional funds, we will be forced to either scale back our business efforts or curtail our business activities entirely. As of March 31, 2015, the Company has an accumulated deficit of $356.2 million, recurring losses from operations, and negative working capital which raise substantial doubt about the ability of the Company to continue as a going concern.

  • beareclawe beareclawe May 10, 2015 10:22 AM Flag

    Re: DC Circ. Opens Door For Stem Cell Regulation By FDA

    Yep

    : )

  • Reply to

    Ocata Key Publications

    by efficacy_20_40 Mar 15, 2015 10:09 AM
    beareclawe beareclawe May 10, 2015 6:44 PM Flag

    Re: Ocata ...

    05/07/15 10-Q
    Cash Flows from Financing Activities

    (excerpt)

    As of March 31, 2015, we have $3,532,602 in cash. As of March 31, 2015, $12,498,749 is available to us through the Lincoln Park financing arrangement. On various dates from April 1, 2015 through May 7, 2015, Lincoln Park purchased 280,892 shares of common stock for cash proceeds to the Company of $1,904,816. As of May 7, 2015, the Company has $10,593,933 available to us through the Lincoln Park financing arrangement.

    We have no expectation of generating any meaningful revenues from our product candidates for a substantial period of time and must rely on raising funds in capital transactions to finance our research and development programs. Our future cash requirements will depend on many factors, including the pace and scope of our research and development programs, the costs involved in filing, prosecuting and enforcing patents, and other costs associated with commercializing our potential products.

    We believe that our current cash balance, and the $12,498,749 available to us under the Lincoln Park financing arrangement as of March 31, 2015, will be sufficient to fund our operations into early 2016. This belief is based on the assumption that our stock price does not realize any significant or prolonged decreases. Our ability to fund our operations through the Lincoln Park arrangement is highly dependent on our stock price. A significant decline in our share price could force us to curtail our operations in part, or entirely. We are continually in discussions with potential investors and collaborators to explore alternative sources of funding which may or may not result in immediate and substantial dilution to our stockholders, so that we may either extend our current cash runway beyond early 2016 or accelerate the rate of investment in our many clinical and pre-clinical programs.

    We cannot assure you that public or private financing or grants will be available on acceptable terms, if at all. Several factors will affect our ability to raise additional funding, including, but not limited to, the volatility of our common stock and the broader public equity market, especially public equities issued by other pre-commercial biotechnology companies, and our ability to raise capital through non-dilutive transactions such as out-licenses. If we are unable to raise additional funds, we will be forced to either scale back our business efforts or curtail our business activities entirely. As of March 31, 2015, the Company has an accumulated deficit of $356.2 million, recurring losses from operations, and negative working capital which raise substantial doubt about the ability of the Company to continue as a going concern.

    : )

  • Reply to

    Ocata Key Publications

    by efficacy_20_40 Mar 15, 2015 10:09 AM
    beareclawe beareclawe May 10, 2015 9:33 PM Flag

    Re: ........, longs will be rewarded.

    Citations:

    Lanza: "Any treatment might not be ready for FDA approval until 2020..."

    Tuesday, October 14, 2014
    Published study shows: ACT treatment restores some sight
    By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF
    (excerpt)
    "We treated the last UK patients last month, and they also have not seen any safety issues related to the transplanted tissues themselves, either," Dr. Lanza said. Advanced Cell now hopes to launch a 100-patient, phase 2 study in Stargardt's patients by the end of the year, according to Dr. Lanza. A second, smaller phase 2 study in patients with age-related macular degeneration would follow, he said. Any treatment might not be ready for FDA approval until 2020, Dr. Lanza said.

    Schwartz: "It's not ready. Maybe in a few years. Maybe not. We have to wait and see. The jury is way out still."

    npr
    Embryonic Stem Cells Restore Vision In Preliminary Human Test
    Rob Stein
    October 14, 2014
    (excerpt)
    For his part, Schwartz says he's just trying to help blind people see better. But he cautions that this work is still at a very early stage. "I don't want patients to come in to their doctor saying, 'Hey, I heard about the stem cells on the radio and I'd really like to get that treatment done, and what do you think?' " he says. "It's not ready. Maybe in a few years. Maybe not. We have to wait and see. The jury is way out still."

    "....market potentially as early as 2019. "

    Press Release
    February 26, 2015
    Ocata Therapeutics Approved for Listing on NASDAQ
    (excerpt)
    The purpose of the pivotal SMD trial is to determine efficacy and safety, as well as to assess relevant functional and anatomical parameters of cell transplantation using an untreated control group, with the intent of bringing a product to market potentially as early as 2019.

    Wotton: "Over in Europe we believe we might be able to get that product to market towards the end of 2018, but we are targeting 2019."

    YouTube
    Dauphin Investor
    Roadshow: Ocata Therapeutics, Inc. (IPO)
    Published on Dec 6, 2014

    : )

  • Reply to

    Ocata Key Publications

    by efficacy_20_40 Mar 15, 2015 10:09 AM
    beareclawe beareclawe May 11, 2015 5:48 AM Flag

    Re: Lanza: "Any treatment might not be ready for FDA approval until 2020..."

    05/07/15 10-Q
    Research and Development Expenses

    (excerpt)

    We expect that R&D expenses will increase from period to period, for the foreseeable future. This planned increase will be driven primarily by our expansion of our clinical operations capabilities as we initiate and scale our Phase 2 clinical trial for AMD and Pivotal clinical trial for SMD. Spending will continue to increase throughout 2015 as our trials are initiated and patients are being enrolled in the trials. We currently work with four clinical sites in the US and two in the UK. We plan to expand the number of sites in both the US and in Europe. In addition, we are expanding the network of consultants and service providers we contract and we also plan to expand our internal workforce. These expansions and the increased spend that will result from these expanded capabilities is consistent with our previously stated plans to transition to become a product development company. Our spending is impacted by the timing of enrollment and treatment of clinical trial patients along with interim results of our many pre-clinical programs. The amount and timing of these fluctuations can be difficult to predict due to the uncertainty inherent in the timing and extent of progress in our research programs, initiation of new clinical trials and rate of progression of existing clinical trials. In addition, the results from our basic research and pre-clinical trials, as well as the results of trials of similar therapeutics under development by others, will influence the number, size and duration of future trials. As our research efforts mature, we will continue to review the direction of our research based on an assessment of the value of possible commercial applications emerging from these efforts. Based on this continuing review, we expect to establish discrete research programs and evaluate the cost and potential for cash inflows from commercializing products, partnering with others in the biotechnology or pharmaceutical industry, or licensing the technologies associated with these programs to third parties.



    We believe that it is not possible at this stage to provide a meaningful estimate of the total cost to complete our ongoing projects and bring any proposed products to market. The use of human embryonic stem cells as a therapy is an emerging area of medicine, and it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval. Costs to complete could vary substantially depending upon the projects selected for development, the number of clinical trials required and the number of patients needed for each study. It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results. Any delay in completion of a trial would increase the cost of that trial, which would harm our results of operations. Due to these uncertainties, we cannot reasonably estimate the size, nature or timing of the costs to complete, or the amount or timing of the net cash inflows from, our current activities. Until we obtain further relevant pre-clinical and clinical data, we will not be able to estimate our future expenses related to these programs or when, if ever, and to what extent we will receive cash inflows from resulting products.

    : )

  • beareclawe beareclawe May 11, 2015 7:03 PM Flag

    Re: This is why ...

    Yet with no products on the market, Ocata brings in almost no revenue. It posted a loss of $36.6 million during 2014, after paying dividend to holders of preferred stock shares, and ended 2014 with a $4.4 million cash cushion. The company withdrew plans for a stock offering in February. Jason Kolbert, an analyst with Maxim Group, cited Ocata’s funding risk in a March report to clients, saying the company needs “funding for the trials and trial data to attract the funding.”

    Citation:

    By Lisa Eckelbecker
    TELEGRAM & GAZETTE STAFF
    Posted May. 4, 2015 at 4:42 PM
    Ocata reports positive transplants in Korean patients

    MARLBORO – More patients have been safely treated for vision disorders with eye cells created by Ocata Therapeutics Inc., the biotechnology company said.

    Ocata said four additional patients have received transplants of the retinal pigment epithelial cells, bringing the total number of patients treated with the cells to 42.

    The most recent findings, which focused on four patients in Asia, were reported last week in the online journal Stem Cell Reports.

    Ocata, previously known as Advanced Cell Technology, is developing medical treatments generated from human embryonic stem cells. It is testing retinal cells as a possible treatment for two disorders that destroy vision, age-related macular degeneration and Stargardt’s macular degeneration.

    In the most recent study, Korean researchers transplanted cells into four Asian patients’ eyes and checked up on them for a year. The patients safely tolerated the transplants, the researchers said.

    “I think it’s exciting that a group on the other side of the planet was able to independently confirm the potential safety and efficacy of pluripotent stem cells,” said Dr. Robert P. Lanza, Ocata chief scientific officer. “Together with our results here in the U.S., I think this bodes well for the future of stem cell therapies.”

    Under Chief Executive Paul K. Wotton, Ocata has launched its new name and completed a reverse-stock split while pushing forward with its research. The company’s stock, which had traded on over-the-counter electronic exchanges, was recently accepted for trading on the Nasdaq Global Market.

    Yet with no products on the market, Ocata brings in almost no revenue. It posted a loss of $36.6 million during 2014, after paying dividend to holders of preferred stock shares, and ended 2014 with a $4.4 million cash cushion. The company withdrew plans for a stock offering in February.

    Jason Kolbert, an analyst with Maxim Group, cited Ocata’s funding risk in a March report to clients, saying the company needs “funding for the trials and trial data to attract the funding.”

    Ocata officials have reported plans to begin the second phase of testing RPE cells in humans this year.

    : )

  • beareclawe beareclawe May 11, 2015 7:07 PM Flag

    Re: This is why ...

    05/07/15 10-Q
    Cash Flows from Financing Activities

    (excerpt)

    As of March 31, 2015, we have $3,532,602 in cash. As of March 31, 2015, $12,498,749 is available to us through the Lincoln Park financing arrangement. On various dates from April 1, 2015 through May 7, 2015, Lincoln Park purchased 280,892 shares of common stock for cash proceeds to the Company of $1,904,816. As of May 7, 2015, the Company has $10,593,933 available to us through the Lincoln Park financing arrangement.

    We have no expectation of generating any meaningful revenues from our product candidates for a substantial period of time and must rely on raising funds in capital transactions to finance our research and development programs. Our future cash requirements will depend on many factors, including the pace and scope of our research and development programs, the costs involved in filing, prosecuting and enforcing patents, and other costs associated with commercializing our potential products.

    We believe that our current cash balance, and the $12,498,749 available to us under the Lincoln Park financing arrangement as of March 31, 2015, will be sufficient to fund our operations into early 2016. This belief is based on the assumption that our stock price does not realize any significant or prolonged decreases. Our ability to fund our operations through the Lincoln Park arrangement is highly dependent on our stock price. A significant decline in our share price could force us to curtail our operations in part, or entirely. We are continually in discussions with potential investors and collaborators to explore alternative sources of funding which may or may not result in immediate and substantial dilution to our stockholders, so that we may either extend our current cash runway beyond early 2016 or accelerate the rate of investment in our many clinical and pre-clinical programs.

    We cannot assure you that public or private financing or grants will be available on acceptable terms, if at all. Several factors will affect our ability to raise additional funding, including, but not limited to, the volatility of our common stock and the broader public equity market, especially public equities issued by other pre-commercial biotechnology companies, and our ability to raise capital through non-dilutive transactions such as out-licenses. If we are unable to raise additional funds, we will be forced to either scale back our business efforts or curtail our business activities entirely. As of March 31, 2015, the Company has an accumulated deficit of $356.2 million, recurring losses from operations, and negative working capital which raise substantial doubt about the ability of the Company to continue as a going concern.

    : )

  • beareclawe beareclawe May 11, 2015 7:50 PM Flag

    Re: This is why ...

    Citations:

    "....market potentially as early as 2019. "

    Press Release
    February 26, 2015
    Ocata Therapeutics Approved for Listing on NASDAQ
    (excerpt)
    The purpose of the pivotal SMD trial is to determine efficacy and safety, as well as to assess relevant functional and anatomical parameters of cell transplantation using an untreated control group, with the intent of bringing a product to market potentially as early as 2019.

    Wotton: "Over in Europe we believe we might be able to get that product to market towards the end of 2018, but we are targeting 2019."

    YouTube
    Dauphin Investor
    Roadshow: Ocata Therapeutics, Inc. (IPO)
    Published on Dec 6, 2014

    Lanza: "Any treatment might not be ready for FDA approval until 2020..."

    Tuesday, October 14, 2014
    Published study shows: ACT treatment restores some sight
    By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF
    (excerpt)
    "We treated the last UK patients last month, and they also have not seen any safety issues related to the transplanted tissues themselves, either," Dr. Lanza said. Advanced Cell now hopes to launch a 100-patient, phase 2 study in Stargardt's patients by the end of the year, according to Dr. Lanza. A second, smaller phase 2 study in patients with age-related macular degeneration would follow, he said. Any treatment might not be ready for FDA approval until 2020, Dr. Lanza said.

    Schwartz: "It's not ready. Maybe in a few years. Maybe not. We have to wait and see. The jury is way out still."

    npr
    Embryonic Stem Cells Restore Vision In Preliminary Human Test
    Rob Stein
    October 14, 2014
    (excerpt)
    For his part, Schwartz says he's just trying to help blind people see better. But he cautions that this work is still at a very early stage. "I don't want patients to come in to their doctor saying, 'Hey, I heard about the stem cells on the radio and I'd really like to get that treatment done, and what do you think?' " he says. "It's not ready. Maybe in a few years. Maybe not. We have to wait and see. The jury is way out still."

    : )

  • beareclawe beareclawe May 11, 2015 10:28 PM Flag

    Re: FDA

    "DC Circ. Opens Door For Stem Cell Regulation By FDA"

    Citation:

    DC Circ. Opens Door For Stem Cell Regulation By FDA
    Law360, New York (March 07, 2014, 5:02 PM ET)
    By Stacie L. Ropka and Chad Landmon, Axinn Veltrop & Harkrider LLP

    (excerpt)

    The court ultimately decided that the stem cell products at issue were a drug under the Federal Drug and Cosmetic Act and/or a biologic drug under the Public Health and Safety Act (“PHSA”).[1] Furthermore, the court ordered a permanent injunction preventing Regenerative from using the autologous stem cells in medical procedures. Recently, the D.C. Circuit affirmed the district court’s decision.[2]

    [1] See U.S.A. v. Regenerative Sciences LLC et al., 878 F. Supp. 2d 248, 257 (D.D.C. 2012).
    [2] U.S.A. v. Regenerative Sciences LLC et al., No.12-5254, slip op. (U.S. App. D.C. filed Feb. 4, 2014).

    The FDA defines human cells, tissues or cellular-/tissue-based products (“HCT/Ps”) as “articles containing or consisting of human cells or tissues that are intended for implantation, infusion or transfer into a human recipient.”[3]

    [3] 21 C.F.R. § 1271.3.

    Stacie Ropka, Ph.D., is counsel in Axinn Veltrop & Harkrider's Hartford, Conn., office, where she advises clients on biologics, stem cells and other tissue-based therapies and diagnostics.

    Chad Landmon is chairman of Axinn Veltrop & Harkrider's intellectual property and U.S. Food and Drug Administration practice groups in the firm's Hartford, Conn., office. Landmon actively litigates and advises clients on patent and FDA matters, including those involving biologics and stem cells.

    : )

  • beareclawe beareclawe May 11, 2015 11:33 PM Flag

    Re: 3 years to market!

    "...... it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval......... It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results....."

    Citation:

    05/07/15 10-Q
    Research and Development Expenses

    (excerpt)

    We expect that R&D expenses will increase from period to period, for the foreseeable future. This planned increase will be driven primarily by our expansion of our clinical operations capabilities as we initiate and scale our Phase 2 clinical trial for AMD and Pivotal clinical trial for SMD. Spending will continue to increase throughout 2015 as our trials are initiated and patients are being enrolled in the trials. We currently work with four clinical sites in the US and two in the UK. We plan to expand the number of sites in both the US and in Europe. In addition, we are expanding the network of consultants and service providers we contract and we also plan to expand our internal workforce. These expansions and the increased spend that will result from these expanded capabilities is consistent with our previously stated plans to transition to become a product development company. Our spending is impacted by the timing of enrollment and treatment of clinical trial patients along with interim results of our many pre-clinical programs. The amount and timing of these fluctuations can be difficult to predict due to the uncertainty inherent in the timing and extent of progress in our research programs, initiation of new clinical trials and rate of progression of existing clinical trials. In addition, the results from our basic research and pre-clinical trials, as well as the results of trials of similar therapeutics under development by others, will influence the number, size and duration of future trials. As our research efforts mature, we will continue to review the direction of our research based on an assessment of the value of possible commercial applications emerging from these efforts. Based on this continuing review, we expect to establish discrete research programs and evaluate the cost and potential for cash inflows from commercializing products, partnering with others in the biotechnology or pharmaceutical industry, or licensing the technologies associated with these programs to third parties.

    We believe that it is not possible at this stage to provide a meaningful estimate of the total cost to complete our ongoing projects and bring any proposed products to market. The use of human embryonic stem cells as a therapy is an emerging area of medicine, and it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval. Costs to complete could vary substantially depending upon the projects selected for development, the number of clinical trials required and the number of patients needed for each study. It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results. Any delay in completion of a trial would increase the cost of that trial, which would harm our results of operations. Due to these uncertainties, we cannot reasonably estimate the size, nature or timing of the costs to complete, or the amount or timing of the net cash inflows from, our current activities. Until we obtain further relevant pre-clinical and clinical data, we will not be able to estimate our future expenses related to these programs or when, if ever, and to what extent we will receive cash inflows from resulting products.

    : )

  • beareclawe beareclawe May 12, 2015 10:43 AM Flag

    Re: PLLLLEEEASE.

    Post another story with less than all the facts.

    : )

  • Reply to

    Will this be the payoff for 8

    by booskiadam Feb 25, 2015 7:08 AM
    beareclawe beareclawe May 12, 2015 10:56 AM Flag

    Re: OCAT $ayer$ are in love with their preciou$ $tory $tock ..... hook, line, and sinker. Yea, year after year for many years..... one after another.

    Quiet, quiet please..... I hear weeping and gnashing of sheeple teeth.

    : )

  • Reply to

    It's Time!

    by blackmarango May 12, 2015 10:59 AM
    beareclawe beareclawe May 12, 2015 11:17 AM Flag

    Re: ..., it's time for the good Dr. to get the show on the road!

    Are you referring to OCATs godlike lanza ........ the man that is dressed in soft garments and sandals ? If so, I'd like to witness lanza perform just ONE supernatural feat:

    Change water into wine,
    Cure every sort of disease and infirmity (painlessly, without delay, and without co$t),
    Feed thousands of people with only a few small fishes and a few yummy almond bear claws,
    Resurrect the dead,
    Calm the wind and sea,
    Walk on water,
    et cetera

    : )

  • Reply to

    A Lot of Uncertainty But One Thing Is Certain

    by hschlauch Feb 11, 2015 7:33 PM
    beareclawe beareclawe May 12, 2015 12:41 PM Flag

    bump for:

    the rabidly optimistic, unconscionable, and conjecture-based,
    hschlauch and the short and distort group,
    the anxious and desperate,
    the spin/pump chimps.

    : ) Giddy up !

  • Reply to

    If not Now? When

    by corruptbusinesss May 12, 2015 12:40 PM
    beareclawe beareclawe May 12, 2015 12:50 PM Flag

    Re: Lanza will be speaking in front of the movers and shakers of the Universe .......... Lanza is the perfect messenger.......

    Does the godlike lanza know the laws governing the heaven of the heavens ? Can he impose their authority on the earth ?

    : )

  • Reply to

    It's Time!

    by blackmarango May 12, 2015 10:59 AM
    beareclawe beareclawe May 12, 2015 6:04 PM Flag

    Re: I'm beginning to wonder if they hit some sort of snag in their Phase II Testing Protocol or Program.

    "The use of human embryonic stem cells as a therapy is an emerging area of medicine, and it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval. It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results."

    Citation:

    05/07/15 10-Q
    Research and Development Expenses
    (excerpt)

    We believe that it is not possible at this stage to provide a meaningful estimate of the total cost to complete our ongoing projects and bring any proposed products to market. The use of human embryonic stem cells as a therapy is an emerging area of medicine, and it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval. Costs to complete could vary substantially depending upon the projects selected for development, the number of clinical trials required and the number of patients needed for each study. It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results. Any delay in completion of a trial would increase the cost of that trial, which would harm our results of operations. Due to these uncertainties, we cannot reasonably estimate the size, nature or timing of the costs to complete, or the amount or timing of the net cash inflows from, our current activities. Until we obtain further relevant pre-clinical and clinical data, we will not be able to estimate our future expenses related to these programs or when, if ever, and to what extent we will receive cash inflows from resulting products.

    : )

  • Reply to

    It's Time!

    by blackmarango May 12, 2015 10:59 AM
    beareclawe beareclawe May 12, 2015 6:54 PM Flag

    Re: FDA

    "DC Circ. Opens Door For Stem Cell Regulation By FDA"

    Citation:

    DC Circ. Opens Door For Stem Cell Regulation By FDA
    Law360, New York (March 07, 2014, 5:02 PM ET)
    By Stacie L. Ropka and Chad Landmon, Axinn Veltrop & Harkrider LLP

    (excerpt)

    The court ultimately decided that the stem cell products at issue were a drug under the Federal Drug and Cosmetic Act and/or a biologic drug under the Public Health and Safety Act (“PHSA”).[1] Furthermore, the court ordered a permanent injunction preventing Regenerative from using the autologous stem cells in medical procedures. Recently, the D.C. Circuit affirmed the district court’s decision.[2]

    [1] See U.S.A. v. Regenerative Sciences LLC et al., 878 F. Supp. 2d 248, 257 (D.D.C. 2012).
    [2] U.S.A. v. Regenerative Sciences LLC et al., No.12-5254, slip op. (U.S. App. D.C. filed Feb. 4, 2014).

    The FDA defines human cells, tissues or cellular-/tissue-based products (“HCT/Ps”) as “articles containing or consisting of human cells or tissues that are intended for implantation, infusion or transfer into a human recipient.”[3]

    [3] 21 C.F.R. § 1271.3.

    Stacie Ropka, Ph.D., is counsel in Axinn Veltrop & Harkrider's Hartford, Conn., office, where she advises clients on biologics, stem cells and other tissue-based therapies and diagnostics.

    Chad Landmon is chairman of Axinn Veltrop & Harkrider's intellectual property and U.S. Food and Drug Administration practice groups in the firm's Hartford, Conn., office. Landmon actively litigates and advises clients on patent and FDA matters, including those involving biologics and stem cells.

    : )

  • beareclawe beareclawe May 13, 2015 7:14 AM Flag

    Re: ...... I'm just saying thanks for the quote.

    The quote if from an OCAT February 26, 2015 press release.

    "The newest date you should be quoting came during the last CC. PW said 2019. Date keeps moving..."

    karl.todd78 • May 11, 2015 6:20 AM
    Hey, beareguy. The newest date you should be quoting came during the last CC. PW said 2019. Date keeps moving up because of ATMP, adaptive pathway, and SPA info. I gave you
    more credit than that....

    05/07/15 10-Q
    Research and Development Expenses
    (excerpt)
    It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results.

    : )

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