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Rockford Coscia  

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  • Arena's Lorqess: A Market Size Analysis [View article]
    Let's put some facts out here. In female rats there was an increase in mammary malignant tumors in the 7-fold therapeutic dose group. There was no increase in humans at the 10mg dosing level over two years. That makes approval a "slim chance"?

    At any rate, I'm fully evaluating the briefing and I'm planning on putting together a piece on it.
    Sep 14, 2010. 10:42 AM | 2 Likes Like |Link to Comment
  • Vivus' Qnexa Panel Bodes Well for Arena's Obesity Drug [View article]
    From most recent draft guidance:

    In general, a product can be considered effective for weight management if after 1 year of treatment either of the following occurs:
    • The difference in mean weight loss between the active-product and placebo-treated groups is at least 5 percent and the difference is statistically significant
    • The proportion of subjects who lose greater than or equal to 5 percent of baseline body weight in the active-product group is at least 35 percent, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant

    BLOOM data:

    47.5% of lorcaserin patients lost at least 5% of their body weight, compared to 20.3% for placebo after 1 year.

    BLOSSOM data:

    47.2% of lorcaserin patients lost at least 5% of their body weight, compared to 25.0% for placebo after 1 year.

    Looks like the hit guidance just fine.
    Sep 2, 2010. 01:01 PM | 1 Like Like |Link to Comment
  • Five Potential Small Cap Biotech Bargains [View article]

    Just saw this one...

    Aug 25, 2010. 05:55 PM | Likes Like |Link to Comment
  • Why Cumberland Pharma Needs Acetadote Approval to Avert Disaster [View article]
    PDUFA delayed until December:
    Aug 20, 2010. 04:28 PM | Likes Like |Link to Comment
  • A Reintroduction to Savient's Krystexxa [View article]
    Two quick notes:

    The date is wrong in this article. The PDUFA date for Krystexxa should read September 14.

    I purchased a position in SVNT Aug 13 @ $14.44/share.
    Aug 14, 2010. 01:04 PM | Likes Like |Link to Comment
  • Arena Pharmaceuticals: The Next Multi-Billion Dollar Biotech? [View article]
    I'm in agreement that there's a lot of potential here and that the drug may be a fantastic new blockbuster (although I will never understand the general aversion to exercise and eating right), I worry about the restrictions of the Eisai agreement. IF we assume $2.5+ billion in sales of Lorc (huge assumption!) Arena looks to make $1.3 billion in payouts from Eisai plus 35ish% of sales - Arena appears to have to cover cost of sales. I think this is hugely limiting and puts a pretty strong cap on Arena's total growth. I'm guessing - entirely guessing - that cost of sales will eat of 20% of the 35% leaving Arena with 15% of sales after cost of sales. So at $2.5 billion in sales they only make an additional $375 million positive cash flows. Discounting the cash flows into the future and adding in the $1.3 billion payout I guess you could say the company could be worth $2+ billion, but there's a ton of assumptions to get there!

    Don't let my minor disagreement let you believe I don't appreciate the data and points you've dug up. Looks great!
    Aug 3, 2010. 04:35 PM | 4 Likes Like |Link to Comment
  • Jazz: Your FDA Panel Primer [View article]
    Excellent question. I plan on writing about this in the future when the panel issues are resolved. Preliminarily, I think Jazz will price JZP-6 in the same $150/month range as other treatments for fibromyalgia and drop Xyrem's price accordingly. Stay tuned for a full explanation.
    Jul 30, 2010. 10:23 AM | Likes Like |Link to Comment
  • Seeking Alpha Celebrates 500,000 Registered Users! [View article]
    In general, SA has provided me with the resources and information to make the change into a complete biotech long/short portfolio. Applying the opinions and expertise of the Seeking Alpha contributors, along with my own background, turned my portfolio from a dog into a consistent winner - and it's been a whole lot more fun!

    The specific time I used a Seeking Alpha article to assist me in making alpha was after I read an article by Joseph Krueger on Affymax (AFFY). Joseph suggested the stock was oversold following an unfavorable statement in the company's clinical trial commentary. After doing my own due diligence, I pulled the trigger and the stock has been on an uptrend since and I hope to realize much more gains as we go forward!
    Jul 29, 2010. 08:38 AM | 1 Like Like |Link to Comment
  • Will MannKind's Afrezza Succeed Where Pfizer's Exubera Failed? [View article]
    Bank of America/Merrill's coverage initiation commentary on June 23, 2010. Part of the report has been posted at:
    Jul 26, 2010. 02:33 PM | 1 Like Like |Link to Comment
  • Arena Weight Loss Drug Looks Promising [View article]
    While I appreciate the article very much, there's a couple things I take issue with:

    "Others were swallowing arsenic, or even a derivative of benzene..."

    I assume you're referring to 2,6-Dinitrophenol, used in diet pills in the 30's. My issue is with 'even a derivative a benzene'. Being a derivative of something doesn't correlate with toxicity of the parent molecule. Sodium benzoate is a derivative of benzene and it's a food preservative. Lorcaserin is even a derivative of benzene. I would say easily a majority of small molecule drugs are in some way derived from benzene.

    "Qnexa, on the other hand, was rejected because it contains phentermine — one of the two drugs in Fen-Phen, which has links to heart damage..."

    Yes, Fen-Phen was linked to heart damage. However, it had nothing to do with phentermine. The heart risk was linked to fenfluramine; the 'Fen' part of Fen-Phen. Qnexa, by no means, carries the same heart risks of Fen-Phen.

    I'd be happy to proof any science-related issues in any articles. Small molecule drugs are my specialty.
    Jul 20, 2010. 10:13 AM | 5 Likes Like |Link to Comment
  • The Sky's the Limit for Avanir Pharmaceuticals [View article]
    Quinine (in tonic water) and quinidine are different molecules. Stereoisomers, yes, but they can give completely different results in vivo. Consider thalidomide, one isomer is fantastic for morning sickness, the other isomer, well... Unfortunately in that case the isomers interconvert in the body.
    Jul 15, 2010. 08:45 PM | 3 Likes Like |Link to Comment