Seeking Alpha

Rockford Coscia

 
View as an RSS Feed
View Rockford Coscia's Comments BY TICKER:
Latest  |  Highest rated
  • Sanofi-Aventis Seeks the Holy Grail of Insulin [View article]
    Comprehensive, well-researched, and unbiased. I really appreciate this.

    Hypothetically, if SNY partners, do they do it before approval on the cheap or after? Is there anyone else that may be courting Biodel besides SNY?
    Sep 27 07:26 PM | Likes Like |Link to Comment
  • Vivus' Qnexa Panel: What Might Have Been [View article]
    I agree, that's a pretty serious drop in calorie consumption. I think the issue here is that, even given the serious restriction, placebo groups only lost 2.5% of body weight over two years (with a peak of -4% after about 30 weeks).

    Vivus plus restriction, on the other hand, caused patients to lose 10.4% and 11.4% in the low dose and high dose treatment levels, respectively, over two years.
    Sep 27 12:25 PM | 2 Likes Like |Link to Comment
  • Vivus' Qnexa Panel: What Might Have Been [View article]
    The patients were required to reduce their food consumption by 500 calories/day - they were not limited to 500 total calories/day.
    Sep 27 07:57 AM | 1 Like Like |Link to Comment
  • Avanir: Insider Selling and Shelf Registration Are No Big Deal [View article]
    EDIT: The term 'insider' in the numbers within the table include >10% holders (including hedge funds and other non-management entities). Please keep that in mind when reading the article.
    Sep 23 04:23 PM | Likes Like |Link to Comment
  • Avanir Pharma's Pending FDA Approval: The Upside Potential [View article]
    You bring up a good point. Because quinidine inhibits CYP2D6, the number of drugs that can prescribed with AVP-923 would be significantly reduced - namely those that are also metabolized by CYP2D6. This will definitely limit the number of patients that will be prescribed AVP-923 (although to what extent I'm not certain).

    I originally intended to bring this up on a future market sizing post but in hindsight it would be appropriate here as well.

    Thanks!
    Sep 20 04:37 PM | 2 Likes Like |Link to Comment
  • Arena’s Lorcaserin: What Now? [View article]
    Really liked this analysis Joseph.

    One question:

    In the event Arena is only required to do additional animal tox studies to rule out tumors beyond rats, doesn't that mean the cash burn shrinks considerably? Also, they have theat 50/50 agreements with Eisai.

    I'm in agreement the fact that this is almost purely speculative at this point. Lots of uncertainty. I don't believe the bank estimates mean much, either. Who out there can really say what the odds of any given outcome are? The valuation of outcomes is fairly straightforward for a good ER team but forget about trying to make reasonable arguments for the likelihood of each outcome.
    Sep 19 03:04 PM | Likes Like |Link to Comment
  • Arena’s Lorcaserin: What Now? [View article]
    Appreciate this point very much. I took the conservative approach and opted against getting into the nitty gritty. There's a ton to get into if you want to do a very accurate valuation and that's why I left it largely up to the reader.

    I was once told by a guy at a hedge fund: "There's a word we have for people with a scientific background that think they have an advantage in biotech investing. Roadkill."

    Trust me, I'm working hard on that financial/accounting background in efforts to not be roadkill. Spent a lot of time with Arena's 10Qs over the past couple months - although all the details of the Deerfield agreement escape me to some degree.

    We need more comments like the above.
    Sep 18 11:39 AM | 4 Likes Like |Link to Comment
  • Arena Pharmaceutical's Lorqess: A Briefing Document Analysis [View article]
    I've followed up on this and I think it's standard practice that tox studies, including carcinogenicity and reproductive toxicity, are not required in the pre-clinical testing. They are required for the NDA (post-phase 3) submission.
    Sep 17 06:58 PM | Likes Like |Link to Comment
  • A Reintroduction to Savient's Krystexxa [View article]
    Hi Nunbid,

    This was written pre-approval. The estimated worth has changed considerably since then.

    For what it's worth, I sold at $19.91. I believe they will get bought, but I just didn't want to play that game. I'm no M&A expert and I'd have virtually zero information for which to base the investment - not a situation I like to be in.

    I've been absolutely impressed with Salveen Richter's coverage of this one - she is the analyst giving the $25 price target - so I think you're in good company here.

    Good luck trading!
    Sep 16 10:34 PM | 1 Like Like |Link to Comment
  • Arena Pharmaceutical's Lorqess: A Briefing Document Analysis [View article]
    Thanks Rads, appreciate the rant.

    I was a little surprised as well (of course!). I didn't bet the farm, and I hope no one else did, but this'll hurt a little on the September ROI. We'll just have to see what happens in the longer term. Maybe some things will be cleared up on the CC tomorrow but I'm really not holding my breath.

    This was a risk I would take again in a second given the data that was available beforehand. There was a lot of upside if there was a positive vote and I don't believe there is a whole lot more downside after the drubbing earlier this week. Time will tell where we ultimately fall.

    I won't be panic selling. Will be taking some time to determine what value is still in this thing and whether or not the price reflects that. May unload half on a good bounce but we'll see.
    Sep 16 04:27 PM | 1 Like Like |Link to Comment
  • Arena Pharmaceutical's Lorqess: A Briefing Document Analysis [View article]
    A couple quick notes:

    First, just wanted to say how excited I am that this came out after market close. Hopefully people find it worthwhile regardless.

    Second, Proschan was a 'no' on the Qnexa panel. Simple typo on my part.

    Third, I've recently learned that the carcinogenicity data could have been collected after IND as that data is usually not required before first-in-human unless there's an obvious reason to be concerned. I really have no idea what the panelists will make of the rodent cancer.

    Fourth, apparently SA doesn't like the phrase 'WTF?'. They would prefer 'what?'. Lesson learned.

    I'm just having fun at this point. I hope things go well but it certainly has been an entertaining run. I'll have my popcorn ready for the "Cancerous Rats vs. Mild Weight Loss but Good Enough According to Guidance" Showdown.
    Sep 15 05:25 PM | Likes Like |Link to Comment
  • Arena Pharmaceutical's Lorqess: A Briefing Document Analysis [View article]
    The Meridia panel may be good news for Lorqess.

    The three panelists that were not on the Qnexa panel but on the Meridia panel - Felner, Segal, and Gregg - all voted to keep Meridia on the market in one way or another. Lorqess has similar efficacy to Meridia but none of the CV issues. We'll just have to wait and see, however, how big the cancerous rat issue really is.
    Sep 15 05:13 PM | Likes Like |Link to Comment
  • Arena Pharmaceutical's Lorqess: A Briefing Document Analysis [View article]
    Thanks John. Much appreciated.
    Sep 15 02:41 PM | Likes Like |Link to Comment
  • Arena's Lorqess: A Market Size Analysis [View article]
    Absolutely correct, John, but in this case the efficacy draft guidance was reprinted almost word for word in the briefing documents. The panel could chose to ignore it, of course, but the FDA says it hits one of the two efficacy endpoints.
    Sep 14 11:23 AM | 3 Likes Like |Link to Comment
  • Arena's Lorqess: A Market Size Analysis [View article]
    I made this exact response to a comment you made on an earlier article on Sept 2:

    "From most recent draft guidance:

    fda.gov/downloads/...

    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:

    arenapharm.com/blo...

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

    BLOSSOM data:

    arenapharm.com/blo...

    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."

    The FDA said almost the exact same in the briefing documents released today. It hits #2 but misses #1. That is enough to be consider efficacious.
    Sep 14 11:16 AM | 2 Likes Like |Link to Comment
COMMENTS STATS
56 Comments
62 Likes