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scistats 122 posts  |  Last Activity: 51 minutes ago Member since: Apr 5, 2009
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  • Now we just wait for them to say it.

    Sentiment: Strong Buy

  • “As the only treatment for metastatic pancreatic cancer following gemcitabine-based therapy that may improve patient survival, ONIVYDE is the first innovation that offers the potential to improve outcomes for this challenging patient population,” said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire. “The approval of ONIVYDE marks a significant step forward in Shire’s focus to develop and commercialize treatments that represent the most promising science in oncology.”

    With this approval, Shire is authorized to market ONIVYDE in the 28 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. ONIVYDE was previously approved in the U.S. by the Food and Drug Administration (FDA), in October 2015.

    Sentiment: Strong Buy

  • Reply to

    Merrimack (MACK) buyout is now a certainty.

    by scistats Oct 22, 2016 9:26 AM
    scistats scistats Oct 22, 2016 9:34 AM Flag

    Sentiment: Strong Buy

  • Apart from the Onivyde platform, Merrimack's antibody candidates are designed to be paired with specific cancer cell types. MACK antibodies will not work for all patients, even those sharing cancer by a common name, e.g. breast cancer.

    Merrimack's antibodies target subpopulations, and while some of these subpopulations are large, perhaps even the majority, this is not what big pharma has traditionally wanted, with some exceptions on the market that may have only served to enforce this old belief.

    Also, MACK's approach naturally requires some up-front failures to prove that a subpopulation actually benefits and can be distinguished from the whole. MM-121 got a black eye in this process, showcased by Sanofi's punt, but this is the nature of the personalized approach.

    Merrimack is not one to let history stop them. They told investors that they plan to match their antibody candidates to specific cancer cell types using Advanced Cell Diagnostic's RNAscope technology to be processed using Leica Biosystems' BOND.

    So, does this mean Merrimack will share the paired diagnostic service income, and will this extra diagnostic cost, which could be significant, be returned in an era of politically promised medical cost caps? Obamacare-II may have little sympathy with these added costs.

    So, here we are with a whole worth more than the parts. In other words, any individual antibody, without economy of scale, may lose money on the market.

    I think the board realizes this and is willing to sell the whole before costs associated with the parts come back to haunt MACK.

    In the hands of the right big pharma, this model could be profitable and is likely the only path forward for a group of many diseases often incorrectly grouped together under the word "cancer". This may be why we are making so little progress and looking to political moonshots.

    This is the part that ex-CEO Mulroy got correct, and it would be shame to see this objective lost ifthe goal is to cure.

    Sentiment: Strong Buy

  • scistats scistats Oct 20, 2016 6:38 PM Flag

    I think the board would sell for 15PPS, and if they formally announced any provision has been removed before Q4 earnings, the cat would be out of the bag. I think they would be wise to remove the provision for legal purposes. Someone could always question if the provision was left intact if Shire made the first move and Crocker simply reciprocated. To avoid this mess, Crocker could propose an agreement, but then he must formally dissolve the provision before moving forward.

    Merrimack is a sitting duck to anyone besides Shire already, even if the specific provision is still intact. What difference does it make? Allergan to take them out.

    I hate to bring politics into the mix, but mainstream financial news has accepted that Hillary is going to enforce price caps across the board just like Canada and the EU. She will have a political mandate. A 15PPS might be a premium if the trials turn out weak. If not, then they could have made significantly more regardless of a price cap. It is a choice.

    Sentiment: Strong Buy

  • scistats scistats Oct 20, 2016 3:34 PM Flag

    Ex-CEO Mulroy is no longer serving at the pleasure of the board.
    I think interim President & CEO Crocker and the board have nullified the conditions previously placed on Shire. Shire can now make offers at will. Otherwise, why bother making any of the changes?

    It is now time to make hay before Hillary begins carving the golden pharma goose to feed her followers while pushing into a natural bull market's end with free education, free healthcare, a higher minimum wage, and military protection to Germany who is affording educational and living opulence for the world, on our dime.

    Sentiment: Strong Buy

  • scistats scistats Oct 19, 2016 11:24 PM Flag

    I am talking about the first and second Onivyde approvals.

    Sentiment: Strong Buy

  • scistats scistats Oct 19, 2016 11:23 PM Flag

    Did you see MACK on Onivyde approval day?

    Reminded me of:
    "Then, on April 28, at 10:01 am central time — just hours before Dendreon’s triumph in Chicago – an anonymous message board author on Yahoo! Finance posted this message: “HIGH PROBABILITY OF MASSIVE BEAR RAID…DNDN [Dendreon] could easily drop 50% on a massive bear raid…its coming today@12:30 pm central.”

    And it did. MACK is heavily manipulated after each set of good news. You can tell because cost has been cut and CEO Mulroy who did not want to sell is gone. Yet, approval comes and the PPS goes down. Manipulation pure and simple.

    Sentiment: Strong Buy

  • scistats scistats Oct 19, 2016 11:18 PM Flag

    It is up to Shire. If they wait and any positive phase 2 news comes from the ongoing trials, along with ramping and expanding Onivyde sales, the PPS is going to easily go back to the double digits. Also, what about the Allergan manufacturing agreement that dovetails with the Onivyde liposome manufacturing still intact in Cambridge at One Kendall Square? If it is the rosacea cream in liposomes that Italian hinted Allergan was doing, this will be on the market in Q2-3 2017. This will take some heat off cash flow and debt. Shire would be well advised to strike now for 15PPS. Otherwise, they could have competition into the 20's, or MACK could partner any of the successful phase1-2. Right now, Shire's website already owns Onivyde. I think the rest will soon follow. I have never seen a big pharma showcase like this.

    Sentiment: Strong Buy

  • scistats scistats Oct 19, 2016 12:35 PM Flag

    Based on yesterdays presentation slides, it looks like JNJ is indeed going all in with imetelstat. Their studies are large enough to identify the 20% of myelofibrosis patients who benefit as well as the Myelodysplastic Syndrome (MDS) patients who benefit.

    The FDA is going to approve both indications, and say it is no skin off their backs if JNJ want to pursue marketing imetelstat for a subpopulation of patients who will benefit. Marginal profitability is not the FDA's problem.

    The real end game is liposome delivery to broaden the market and take side effect off of the table. Imetelstat 1.0 will be first though.

    If animal model work is happening for liposome delivery, and I have no doubt that it is, we will be the last to know about it. JNJ is not going to stop with imetelstat 1.0. If that were the case, they probably would have not even started the imetelstat program or kept it going or mentioned it in their presentation. They have bigger plans here than marginal gain. They will put it on target one way or the other.

    Sentiment: Strong Buy

  • scistats scistats Oct 18, 2016 4:04 PM Flag

    I think it will happen.
    Just need some time.

    Sentiment: Strong Buy

  • Reply to

    ONIVYDE® is FEATURED on SHIRE'S website!

    by scistats Oct 18, 2016 3:58 PM
    scistats scistats Oct 18, 2016 4:01 PM Flag

    4:01 PM 10/18/2016
    Now or hold your peace.

    Sentiment: Strong Buy

    ONIVYDE® Receives EC Marketing Authorization
    Learn about our latest advancement in oncology which offers pancreatic cancer patients and oncologists a new option post-gemcitabine-based therapy.

    (Get in now or hold your peace. 3:59PM 10/18/2016)

    Sentiment: Strong Buy

  • Reply to

    No PR? No mention on company website?

    by sixmilliondollarbios Oct 18, 2016 2:21 PM
    scistats scistats Oct 18, 2016 3:54 PM Flag

    Shire has a big spread about it on their website.
    They may have told Merrimack Pharmaceuticals to back off their press release?

    I think MACK is indeed officially undervalued, and we are being played pending a massive accumulation for exactly the reasons you have listed.

    Sentiment: Strong Buy

  • scistats scistats Oct 18, 2016 12:03 PM Flag

    I believe the September 23, 2016 extended agreement between Johnson & Johnson and Geron brings GRN163 in the fold. Investors will probably have to wait for at least one imetelstat trial success to begin to see GRN163-liposome on the Janssen phase 1 radar. They need to get the preclinical work done first, but the Sept. 23 press release suggests things are moving forward with something other than GRN163L. Janssen also probably wants to make sure they can get through the current trials without any adverse events and then move the ball forward with the FDA for expedited approval strategies. How soon they might announce such plans is up to them, and there is no motivation to release the news given their big pharma status and the fact that they already said they now own it.

    Sentiment: Strong Buy

  • scistats scistats Oct 18, 2016 11:14 AM Flag

    John A. Scarlett, M.D., and by proxy, Janssen and Johnson & Johnson stated a disclaimer already explaining that the patients in trial NCT02426086 are a never before evaluted myelofibrosis patient cohort of extremely difficult to treat patients who have been through the wringer and may or may not respond as Dr. Tefferi's patients did. Dr. Scarlett mentioned this disclaimer several times the last time he spoke. Disclaimer, disclaimer, disclaimer....

    Sentiment: Strong Buy

  • scistats scistats Oct 18, 2016 10:30 AM Flag

    This also says something about doctors who seek profit beyond their salary.

    Really, most doctors pull inovation off the shelf and prescribe per the instructions or pre-established standard of care flow-chart.

    What do they really know about biochemistry at the research level? A few, but not many!
    Patent imetelstat...pfffffffff...give me a break!

    Sentiment: Strong Buy

  • scistats scistats Oct 18, 2016 10:11 AM Flag

    Dr. Ayalew Tefferi, M.D., Mayo Clinic, got excited about refractory anemia with ring sideroblasts as a possible imetelstat indication. He filed an imetelstat patent for this based on patient genetics/markers. How he got approval from Geron to patent anything related to imetelstat is unknown. In my opinion, he should never have done this. It makes him look like a profiteer of medicine instead of a classic Mayo purist. He would have been much better of staying out of this and written a book about helping others as a doctor.

    Anyway, upon investigation, his idea did not pan out. Imetelstat works for 20% of myelofibrosis patients at the current high dose, but it does not so well for refractory anemia with ring sideroblasts.

    Here is what Dr. Tefferi had to say about this:
    "The meager depth of response in the current study, compared with the aforementioned report in myelofibrosis, might reflect either different disease biology or suboptimal drug dose."

    So, Dr. Tefferi is no longer "in charge" of imetelstat, and therefore, he is not excited (in my opinion). It take a lot more than just curing a few myelofibrosis patients to get him excited, or so he said. I agree with you, emmersonfranklin, and perhaps we all collectively are saying: #$%$!!!!!!!!!"

    The lime light is now on Johnson and Johnson who can do what Dr. Tefferi could not, which is get the drug to market for at least one indication AND package the technology into a liposome for next generation imetelstat 2.0, which is likely in the works per the recent GERN-JNJ oligo deal and the liposome packaging of imetelstat clearly and explicitly spelled out in the GERON patents that linke directly to JNJ's liposome patent. See my other post today for the JNJ patent numbers cited in the GERON imetelstat patent describing liposome packaging.

    Sentiment: Strong Buy

  • scistats scistats Oct 18, 2016 9:34 AM Flag

    September 23, 2016
    Janssen will get global exclusive rights to Geron’s proprietary oligonucleotide backbone chemistry. Oligonucleotides are short nucleic acid polymers used in research, genetic testing and forensics."

    Janssen will put the original GRN163, a 13-mer oligonucleotide N3′→P5′ thio-phosphoramidate, (without the lipid tail, i.e. GRN163L) into an immuno-liposome for delivery for pancreatic cancer (1,2).

    1.) Telomerase inhibitor Imetelstat (GRN163L) limits the lifespan of human pancreatic cancer cells. PLoS One. 2014 Jan 7;9(1)
    2.) The telomerase inhibitor imetelstat depletes cancer stem cells in breast and pancreatic cancer cell lines. Cancer Res. 2010 Nov 15;70(22):9494-504

    Sentiment: Strong Buy

  • GERON - United States Patent Application 20150337314

    "While the compounds of the invention have superior characteristics for cellular and tissue penetration, they may be formulated to provide EVEN GREATER BENEFIT, for example in liposome carriers. The use of liposomes to facilitate cellular uptake is described, for example, in U.S. Pat. No. 4,897,355 and U.S. Pat. No. 4,394,448. Numerous publications describe the formulation and preparation of liposomes."

    The patents mentioned in the above GERON patent are owned by the following companies:

    U.S. Pat. No. 4,897,355 - Syntex (U.S.A.) Inc. (Palo Alto, CA)
    Syntex was integrated into the Roche group in 1994.

    U.S. Pat. No. 4,394,448 - Sequus Pharmaceuticals, Inc. (formerly known as Liposome Technology Inc.) operates as a subsidiary of ALZA Corporation. Mar 27, 2001 Johnson & Johnson to Merge With ALZA Corporation In $10.5 Billion Stock-for-Stock Transaction.

    Sentiment: Strong Buy

132.07+2.07(+1.59%)Oct 21 4:00 PMEDT