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Advanced Medical Isotope Corporation Message Board

buckfarmer777 177 posts  |  Last Activity: Apr 15, 2013 10:19 PM Member since: Aug 19, 2009
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  • On Market Playground website:

    InVivo Therapeutics Holdings Corp. (OTC:NVIV) shares have been on a tear since January 2nd’s closing price of $1.75 to Friday’s close of $3.30, up just over 88% YTD. The company is a non-stem cell play on a highly unmet regenerative therapy market, most notably spinal cord injuries (SCI). InVivo’s exciting platform utilizes three different approaches to treating SCIs: (1) a biocompatible polymer scaffolding device to treat acute SCI, (2) a biocompatible hydrogel for local controlled release of methylprednisolone to treat acute SCI, and (3) a biocompatible polymer scaffolding device seeded with autologous hNSCs to treat acute and chronic SCI. In terms of near term catalysts, I believe investors should research and focus on the company’s biocompatible polymer scaffolding device. In April alone, InVivo released two significant press releases updating investors on this exciting portion of the company’s product line. The device is intended to prevent secondary damage due to immune response and inflammation after an acute SCI. This secondary damage can result in additional impairment of the damaged spinal nerve tissue including killing of neural cells and scarring, both not only impeding the healing process but also exacerbating an already critical injury. The polymer scaffolding device is designed to work as a type of “patch”, implanted and placed directly onto the damaged spinal cord. This implantation follows stabilization of the spine itself at the injury site by rigid pedicle screws. The scaffolding device is then applied directly to the cord injury and secured with a “Dura Patch” where it serves as a barrier to protect the exposed and injured spinal cord.

    On April 4th, InVivo (NVIV) announced that it had received approval for its request filed with the FDA for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. The designation is significant in that it is the medical device equivalent of an Orphan Drug

    Sentiment: Buy

  • On Market Playground: Here is an excerpt....

    Biodel Inc. (NASDAQ:BIOD) is a development phase pharmaceutical company focusing on the large market indication of diabetes. Last Monday, BIOD common shares started the week with a dip below $2.50 per share, the lowest the stock has traded since January 23rd. However, a high-volume day Wednesday pushed shares up, closing the week at $2.91. With no news of note, I believe investor interest is beginning to return in anticipation of a couple of significant upcoming catalysts.

    On March 28th, Biodel announced that it had completed enrollment in a 130 patient phase 2 trial evaluating its ultra-rapid-acting prandial (mealtime) insulin candidate BIOD-123 for the treatment of diabetes. The trial is evaluating BIOD-123 versus standard of care Humalog in Type 1 diabetes patients as fast-acting meal-time insulin products for an 18-week period. In an earlier phase 1 trial evaluating two of Biodel’s clinical candidates in order to ascertain which would go onto the phase 2 clinical trial, BIOD-123 demonstrated that it was 64% faster than Humalog in mean times to half maximum insulin concentrations (p

    Sentiment: Buy

  • Small capitalization late-stage pharmaceuticals can often escape the interest of the investor masses due to a host of reasons ranging from lack of public awareness, difficult to comprehend product models, small targeted markets, previous clinical failures or a multitude of other reasons. However, as key catalyst dates approach investor interest may quickly appear/return with sharp share price increases benefiting those with the foresight or luck to have long positions well before the masses. I wish to present what I believe to be three late-stage (having Phase 3, pivotal studies underway) pharmaceuticals that could offer substantial upside in the days, weeks or months ahead in anticipation of data release. There are many ways to invest in such catalysts ranging from a "biorunup" approach which consists of a complete or partial exit just before the data are presented (eliminating much of the risk associated with a possible clinical failure) to the long positions in which shares are held through the data presentations but then exited upon share spikes after positive data (hopefully) are presented. Some investors may even opt to hold all or part of the original shares through New Drug Applications (NDAs), FDA advisory committees or even regulatory decisions in the form of FDA decisions. Regardless of the investment strategy utilized, solid (and early) entry levels help to maximize the potential gains and guard against more substantial losses than later entries when share prices have started trending higher.

    PLC Systems (PLCSF.OB) is the smallest market capitalization company I wish to present. With a market capitalization of $5.4 million and a 52-week range of $0.11-$0.34, the company is currently flying under the radar. Is PLC Systems trading at these levels due to it only having early stage clinicals with no marketed product? Actually, it is quite the opposite. On December of 2007, the company received the European CE Mark for its RenalGuard System™. The product is

    Sentiment: Strong Buy

  • 'Top Of The Class' Small Pharma Investments For 2013

    By the "should be analyst" Chemistfrog!

    As an individual investor focusing a large portion of my portfolio on development-phase small pharmaceuticals, I have had my fair share of disappointing choices with failed clinical trials and negative FDA decisions on drugs and medical devices. However, gains made from good decisions have both motivated and enabled me to continue investing based on my own choices. On January 11th, 2012, I released Top of the Class Biotechs for 2012, which profiled four companies whose common shares I believed could lead their peers with solid share price gains for the year. With two of the choices having a disappointing year, but with the remaining two having a phenomenal year, investments spread equally between the four choices would have been highly lucrative as indicated below. A nominal long investment in each of the four choices on the day the article posted would have netted a gain of well over 100% on the year, better than many investors would hope for who invest for the longer term. Although no guarantees can be made that this type of gain is possible for my three 2013 candidates, the example does present to investors the types of gains possible for successful choices in only a small portion of their total decisions. These are development-phase companies and there is potential for substantial losses. Gains could also be considerably larger than the roughly 100% net gain below, although I personally would be skeptical of such a possibility.

    Small Pharma Class Leader in Pain Relief

    AcelRX Pharmaceuticals (ACRX) is a $99.4 million market capitalization pharmaceutical company that has been reporting out solid data throughout the year on its lead product candidate, ARX-01. The drug has been evaluated in three Phase III trials with one having data released just recently and the other two trials' data expected in Q1 2013. ARX-01 is a sublingual (under the tongue) administration of the approved and marketed opioid, sufentanil. The drug is highly effective for pain relief, but its currently approved IV administration technique causes a quick onset of activity and a rapidly waning concentration in the patient's blood plasma, rendering its efficacy short-lived. ARX-01 attempts to address the issue by using AcelRX's proprietary Nanotab® technology to administer the drug sublingually. This administration technique allows for a rapid yet consistent infusion into the patient's blood stream, but without the initial spike of concentration in blood plasma.

    Sufentanil is a very effective analgesic (pain reliever), and its more optimal administration may prove to be highly profitable for the company, pending FDA approval for ARX-01 in the coming months. On November 15th the company released topline data from one of its three Phase III trials wrapping up in Q4 2013. The trial evaluated ARX-01 versus IV PCA (patient controlled analgesia) morphine in 359 patients for the treatment of acute post-operative pain immediately after having major abdominal or orthopedic surgery. The trial met its primary endpoint of "non-inferiority in patient global assessment (PGA) with method of pain control" relative to IV PCA morphine with a promising correlation of (p

    Sentiment: Strong Buy

  • http://seekingalpha.com/article/1051061-favorable-acelrx-stock-offering-price-may-catalyze-the-company-s-share-price

    AcelRX Pharmaceuticals (ACRX) has had an impressive year behind it culminating with the completion of three phase 3 trials for its NanoTab™ platform's ARX-01. The therapy is a sublingual caplet containing sufentanil, an opioid analgesic currently marketed for IV and epidural anesthesia. An effective analgesic, sufentanil is typically administered intravenously for the control of many types of pain. However, its effectiveness wanes after an initial spike of the active ingredient in the patient's blood plasma. ARX-01's goal is to address the issue by administering a constant amount of the active ingredient by absorption through the skin of the sublingual (under the tongue) caplet.

    The first of the company's phase 3 topline data sets, for its NanoTab™ system, was announced on November 15th with positive results. Data indicated the therapy was "statistically superior to IV PCA morphine for the PGA (patient global assessment) endpoint (p=0.009)." The trial was evaluating ARX-01 versus IV-administered PCA morphine to control post operative pain. Data was impressive and likely indicative of the results probable for the remaining two trials whose data is scheduled to be released in Q1, 2013. Shares soared on the news, with a new 52-week high of $5.25 reached.

    Share price has gradually trended down since the news, with acceleration in decline due to an announcement by the company on Wednesday, December 5th that the company had registered an offering for 10 million shares. The price on the offering was not given, and shareholders began panicking. The company's stock sold off from the closing trade on the Tuesday of $3.94 to the opening trades on the 5th of $3.65. The share price continued to trend down with a closing price on Thursday of $3.31. The market has not been as friendly recently with offerings, partly due to the huge discount of Supernus Pharmaceuticals' (SUPN) 6 million share offering. Trading in the $12-$14 range for much of the month since its October 22nd FDA approval for its epilepsy drug, Oxtellar XR™, Supernus' offering was priced at $8.00 per share, a near 20% discount on the previous day's close and a 33% discount on the $12 range it was trading at just a couple of days before.

    In what could catalyze AcelRX's share price today, the company announced after the markets had closed yesterday evening that it was pricing its offering at $3.31, at that day's closing price. Not priced at the discount that many likely expected, the news may catalyze the company's share price to the upside not only on Friday but also well into Q1, 2013. With the remaining two phase 3 trials set to present in Q1, investor interest will likely return in anticipation of the data. Investors interested in the company should preview the phase 2 data with the measured reduction in pain intensity relative to the IV PCA morphine of p

    Sentiment: Buy

  • buckfarmer777 buckfarmer777 Nov 27, 2012 2:59 PM Flag

    Nice summary of upcoming catalysts for each of these three! Upside potential in each is pretty good in coming days/weeks.. awesome!

    Sentiment: Buy

  • buckfarmer777 buckfarmer777 Nov 12, 2012 9:20 PM Flag

    Any opinions on where this might good with good data presented? I'm assuming + $0.40 would be a given, but this is for a larger patient population so maybe more?

    Sentiment: Buy

  • buckfarmer777 buckfarmer777 Nov 12, 2012 5:36 PM Flag

    Bullish on ONCS and researching INO. I'm pleased with what I see so far. Chemistfrog article turned me onto it... It took a recent dip but looks to be recovering nicely. Link to his/her article: http://seekingalpha.com/article/1000421-upcoming-melanoma-conference-is-an-excellent-source-of-small-pharma-investor-information

  • Great writeup here by Chemistfrog! Goes into many companies presenting data this week at the Melanoma conference. http://seekingalpha.com/article/1000421-upcoming-melanoma-conference-is-an-excellent-source-of-small-pharma-investor-information

    Sentiment: Strong Buy

  • buckfarmer777 buckfarmer777 Oct 14, 2012 12:01 AM Flag

    Agreed. I'm more bullish than ever and wish I had bought more down lower. I'll add more Monday now and sell half on the way up and maybe hold half through the PDUFA date (but will probably be surprised by an early approval). Good luck!

    Sentiment: Buy

  • New article out this morning on EXEL. I'll have to reread it a few times, but it sure seemed solid!

    http://seekingalpha.com/article/920461-arqule-s-tivantinib-failure-and-exelixis-cabozantinib-pdufa-is-there-a-correlation

    Sentiment: Buy

  • buckfarmer777 by buckfarmer777 Aug 12, 2012 9:35 PM Flag

    As I watched this trade after hours on Friday and look at all the negative posts here and in iHub I realize that I will now open a new position in PWAV in PM on Monday. People bash these for a reason, and it's not because they have legitimate traders' or investors' interests in mind (obviously). EVERYBODY EXPECTED POOR EARNINGS! That's why the share price is well below $1 duh!! If they expected nice or fantastic earnings the PPS wouldn't be down here. In my opinion, we've seen or will see bottom in pre-market on Monday. The company is hiring for a reason and people are bashing here for one of two reasons... trying to get cheaper shares or trying to get PPS lower because they've shorted the stock.

    Use your common sense.. Happy trading and have a great week!

  • Just found this, they're hiring?! http://www.linkedin.com/company/165524?trk=NUS_CMPY_FOL-nhre

    I think they're turning things around....


    Powerwave Technologies is hiring: Peoplesoft Sr. Technical Developer in Orange County, California Area
    Share Careers at Powerwave Technologies See more jobs 15 days ago
    Powerwave Technologies is hiring: Payroll Supervisor in Orange County, California Area
    Share Careers at Powerwave Technologies See more jobs 15 days ago
    Powerwave Technologies has a new Trainee Engineer

    srikanth rapolu is now Trainee Engineer
    Like (1) 17 days ago
    Powerwave Technologies is hiring: Strategic Account Manager in Orange County, California Area
    Share Careers at Powerwave Technologies See more jobs 18 days ago
    Powerwave Technologies is hiring: Sr. RF Project Engineer in Orange county, ca
    Share Careers at Powerwave Technologies See more jobs 22 days ago
    Powerwave Technologies is hiring: Sr. RF Test Engineer in Orange County, CA
    Share Careers at Powerwave Technologies See more jobs 22 days ago
    Powerwave Technologies has a new Engineer-I

    sudhakar amadakayala is now Engineer-I
    Like 1 month ago
    Powerwave Technologies has a new Trainee Engineer

    Harinath Gandla is now Trainee Engineer
    Like 1 month ago
    Employees (844)
    3rd
    National Sales Manager - EEE / Mobile Solutions
    Bob N., Orange County, California Area
    3rd
    VP/GM Global Wireless Solutions
    Keith K., Washington D.C. Metro Area

    Sr. Principal Engineer(Advance Radio Solutions- 4G/3G)
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    Vice-President, Europe / Powerwave LLC CEO
    Julia S., Greater Chicago Area

    Chief Technology Officer & President,Global Business Units
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    Type
    Public Company
    Company Size
    1001-5000 employees
    Website
    http://www.powerwave.com
    Industry
    Telecommunications
    Founded
    1985
    Headquarters

    1801 E. St. Andrew Pl.
    Santa Ana, CA 92705
    UNITED STATES
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  • Reply to

    Roche comments - not an issue for them

    by fgnoms Aug 2, 2012 3:05 AM
    buckfarmer777 buckfarmer777 Aug 2, 2012 7:14 AM Flag

    Excerpt from the above PR

    Wall Street analysts, who have an average $12 price target on Halozyme, attribute approximately $7 per share to products co-developed with Roche.
    Discounted cash flow estimates suggest that there is significant upside even if issues with HyQ or Cinryze persist and programs under Roche are the only remaining assets.

  • buckfarmer777 by buckfarmer777 Jun 1, 2012 2:15 PM Flag

    Awesome work!!

    http://seekingalpha.com/article/631101-immunocellular-therapeutics-ict-107-to-impress-at-asco-2012?v=1338565728&source=tracking_notify

    Nice ending as well:

    With a smaller targeted market group than many cancers, newly-diagnosed glioblastoma treatment could start showing up on the radar for many investors as therapies begin to improve enough to a point that real hope is offered. ImmunoCellular Therapeutics' ICT-107 appears to be leading the charge in the fight against the dreaded disease. Although presented data is currently all from the Phase I trial, the data is simply too impressive to ignore, with 38% of patients still alive after 4 years with some now over the 5-year benchmark in which they could be considered clinically "cured". Anticipation in the coming months should only build as follow up Phase I data continues and the Phase II appears to rapidly complete enrollment and start marching toward interim data for that trial. Northwest Biotherapeutics' DCVax painfully-slow enrollment rate could now speed up with the recent changes in clinical sites. Investors do need an update on enrollment completion, which is something lacking in recent press releases, including a very recent one on May 17th. With all the success of its Avastin therapy behind and in front of them, Roche's blockbuster drug isn't expected to significantly improve PFS or OS based on earlier trials in which an approval was given not based on those criteria, but rather on tumor response only. Celldex doesn't appear to impress a huge number of investor with its CDX-110 data, although the results are indeed positive. Numbers certainly show improvement, but approval will mean a smaller target set of patients with 25-30% of GBM patients targeted. Celldex's future appears more tied to its CDX-011 metastatic breast cancer drug with impressive data being announced on May 23rd giving the targeted breast cancer patients hope. The race to a GBM cure is progressing at a feverish pace with a very likely winner being assumed at ASCO 2013 and realized at ASCO 2014. Patients, investors, and large pharmaceuticals will be watching this race closely for their varied reasons. Hope could be coming and is likely in the form of at least one of the above-mentioned companies.

  • buckfarmer777 by buckfarmer777 Feb 28, 2012 10:46 PM Flag

    Not a bad posting. Nothing pumpy it appears, just a chronology of events. The guy usually only writes on biotechs...

    http://seekingalpha.com/instablog/399559-chemistfrog/333261-sourcinglink-net-silence-broken

  • Reply to

    hdogtx will be pumping this soon..

    by darrellvolentine Jan 14, 2012 9:13 PM
    buckfarmer777 buckfarmer777 Feb 28, 2012 10:43 PM Flag

    Sorry, but HDOGTX won't be pumping this. This is to legitimate! LOL! Have a look at his iHub postings..... Nothing on it as of late.. He might have tweeted it to do a quick flip, but I'm confident he won't be pushing it now that it appears he has flipped out of his position...

  • http://seekingalpha.com/article/319764-pharma-leaders-emerging-in-immunotherapy-approach-to-fighting-glioblastoma

    Hi all! I've been considering opening a position in IMUC over the last month or so, but this article forced my hand quicker than I had planned! The company is obviously on the forefront in fighting this devastating brain tumor! I actually opened a position yesterday after I had thoroughly read the article and have high hopes for where they may be heading. I'm not sure if anybody saw my comments, but I emailed the "Chemistfrog" author at Seeking Alpha, but haven't heard back from him yet. I've scanned through his other articles and am very impressed! I think his writings may be the beginning of my biotech portfolio (okay, not blindly though).

  • Reply to

    Nicer Seeking Alpha

    by riach.biatch Jan 16, 2012 12:10 PM
    buckfarmer777 buckfarmer777 Jan 17, 2012 11:04 AM Flag

    Good morning all! Nice write up! Does anybody know anything about the author? This was a phenomenal amount of research and is certainly a great starting point as he said as well as a great overview of the treatment progression from early to modern advancements as well as future potential.

  • buckfarmer777 by buckfarmer777 Jan 3, 2012 10:31 PM Flag

    Has anybody here noticed the volume and PPS surge on SNET over the last month? Something's up! Quiet accumulation, and not just a discreet few like in a preload... Somebody's buying quietly and consistently. They've posted a few financial updates over the last 3 weeks as well... I've opened a starter and will watch the trading behavior. I think this could be a real gem in the making.........

ADMD
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