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  • News Stories Miss the Point as Depomed Approaches FDA Target Date [View article]
    Geoffreygc40,

    You did not and could not post the Complete Response Letter ("CRL")

    You are posting a press release and 10-k, which is the companies abbreviations of the CRL.

    I am not going to respond to all of your posts, I think readers can understand how you contradict yourself.

    But to boil down my concerns with your supposed argument.

    "the appropriate next steps" were to repackage public data, repackage their own data, and submit as a 505b2. If the FDA was concerned about cancer wouldn't they ask for more animal/safety studies? Yes, they would. Did they, no they didnt. What happened? XNPT filed 505b2. Why would they do that? Because by referencing neurontin and submitting repackaged data, they hope to convey minimal risk just as Lyrica did and just as DM1796 will.

    I suggest you review the fibromyaglia approval process for Lyrica, this will help you understand why this is not an indication issue.

    Your links impart no new information, no new insight, and are already known. I dont have beef with you, but I appreciate your discussion here, maybe we can both learn something.
    Jan 4 03:17 PM | 1 Like Like |Link to Comment
  • News Stories Miss the Point as Depomed Approaches FDA Target Date [View article]
    On paper, they are different. That's why Horizant was rejected. That's why it's a "cancer issue" and an application issue.

    I'm not the FDA, I cannot sit here and say that if XNPT's drug showed similar findings when compared to nuerontin that it would be approved or that if they filed as a 505b2 like Lyrica that they would be approved

    I can however say that because XNPT had [different] cancer-causing findings and thats the paramount reasons they rejected as an NCE. I think thats fair.

    Your point on the statements: "checmially altered", "different cancer-causing properties", etc.... these are SA speak for "NCE", and "different cancer-causing properties" :)

    The bottom line is that from XNPT own press release and CCs, this has been a "cancer issue", this is the publicly stated reason for rejection. Horizant's cancer causing properties were different than neurontin. In my opinion, the FDA cannot make the assumption that this is benign, it needs a 505b2 to make that judgment.

    I appreciate your points and this discussion.
    Jan 4 02:34 PM | 1 Like Like |Link to Comment
  • Changing the Perception of the Biotech One-Trick Pony [View article]
    Ase-

    It's not for the faint of heart- though it looks like VVUS, depending on when you got in, is making a come-back. I've alway's liked it
    Dec 26 04:23 PM | 1 Like Like |Link to Comment
  • Going Bullish on Depomed [View article]
    yes, I can sum it up for you.

    XNPT filed as an NCE and provided relatively little safety data. They have since filed as a 505b2 which allows them to use gabapentin's safety data.

    When Depomed's application is reviewed by the FDA, DEPO has referenced all the historic gabapentin studies. Basically, a non-approval from the FDA would imply that they think gabapentin is not for market... and thats just not happening.

    Unless DEPO screwed up the NDA, there is no reason why they shouldn't get approval. Remember that their acuform technology is all GRAS, and nothing more than the polymers used to fluff soft-serve icing.

    The relationship to XNPT was an example of the mass stupidy presents a buying opportunity.

    Cheers, and good luck.
    Dec 17 11:11 PM | 1 Like Like |Link to Comment
  • Currently Trading Below Cash, Medical Device Manufacturer Cutera Worth a Long Look [View article]
    The "thesis" is that it is worth a quick look -- a few positives and a few negatives are provided -- make your own conclusions.
    Dec 2 09:48 AM | 1 Like Like |Link to Comment
  • Trading MELA Sciences' Pending FDA Decision [View article]
    John - the package (i.e. 3/4/9/10) was executed as a single trade 3~4 times (to my surprise, at progressively better prices). Answering your question, once the trade is in place, you lose control of the short elements -- i.e. you can be assigned. Also, I looked at practically ever angle on this name and decided the path I took was the best course of action. Good luck with your own trading.
    Nov 12 11:43 AM | 1 Like Like |Link to Comment
  • Incyte Pharmaceuticals’ JAK: Just Another Kinase? [View article]
    hoopdreamerz-

    HGSI- "We achieved our first product sales in 2009 by delivering 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalation anthrax"

    VRTX- "Lexiva® (fosamprenavir calcium) is an HIV protease inhibitor developed by Vertex in collaboration with GlaxoSmithKline (GSK). Lexiva is dosed as two pills twice daily and as two pills once daily boosted by ritonavir and one pill twice daily boosted by ritonavir. Lexiva was approved in the U.S. in October 2003, and received approval in the E.U. under the trade name Telzir® in July 2004"
    Oct 6 11:30 AM | 1 Like Like |Link to Comment
  • 4 Lessons From a Review of Arena Articles [View article]
    If you take away all the consultants- who the heck's left with the best knowledge of the drugs?
    What do you think the expert panel's for
    Sep 19 01:14 PM | 1 Like Like |Link to Comment
  • Crossing the Biotech 'Valley of Death': From Innovation to Cure [View article]
    Agree- though been focusing on drug developers vs. device/diagnostics.
    But that's were the - what did I call it - integrated pharma? - model comes into plat. They'll be forced to incorporate diagnostics in development as targeted drugs split up the size of patient groups. Only better outcomes will justify their high prices.
    Oh, another problem with getting diagnostics early is its very expensive. Even with targeted drugs, choosing the right marker, validating, collecting- crazy amounts of data.
    Diagnostics companies are so fragmented- if fast growing. Perhaps a leader will emerge and roll them up.
    Sep 19 12:13 PM | 1 Like Like |Link to Comment
  • Big Pharma: Why In-Licensing Is Not the Cure [View article]
    Thanks Tom-

    I totally agree with you about the FDA
    Aug 29 12:13 PM | 1 Like Like |Link to Comment
  • Adventrx Pharmaceuticals: Primed to Jump or Drop? [View article]
    Thanks John. The technology itself seems very interesting (thus Icahn's interest). The 10-K did confirm the huge potential of ANX-514...assuming the FDA is positive w/ ANX-530 this would have obvious positive knock-on impact for ANX-514 and ANX share price...
    Aug 12 11:08 AM | 1 Like Like |Link to Comment
  • Vertex: A New Era In HCV Drug Development [View article]
    Hi Frank,
    Thanks.
    Actually, I pretty much agree with your view that docs will be fairly slow to change once they get comfortable with the drugs they're using. I see most new regimens still being boosted by interferon+riba for some time.
    It will be interesting how this market works out because unlike HIV, these patients will actually get cured in a matter of months instead of staying on meds their whole lives. Also, rate of new infections in industrialized nations slowing. Most patients will be in developing countries- they'll have to figure out how to make the bucks there.
    Jul 20 01:11 PM | 1 Like Like |Link to Comment
  • Vivus, Arena and Orexigen Investors All Worried About Qnexa FDA Panel Review [View article]
    "simply a bit 'quick to print' maybe or just very busy... "
    Ha ha, I like that
    Jul 13 02:43 PM | 1 Like Like |Link to Comment
  • Gilead Sciences: Undervalued [View article]
    my bad, typo
    Jul 12 01:45 PM | 1 Like Like |Link to Comment
  • Bristol-Myers Squibb: Attractive, With a Couple Hiccups [View article]
    Thanks Guys for your support.

    Regarding HSP-90, I feel that's gonna be huge. Lots of competition in the space, but like Vegf before it, my feeling is its going to have a major impact on oncology.
    Jun 29 12:51 PM | 1 Like Like |Link to Comment
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