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Federal Home Loan Mortgage Corporation Message Board

bergycb 78 posts  |  Last Activity: Jul 8, 2016 3:19 PM Member since: Sep 16, 2009
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  • On one hand the price action recently has been encouraging, but otoh the volume imo has been somewhat anemic. If theres been some sort of leak one way or the other it would appear to be on very small scale?

  • bergycb bergycb Jul 8, 2016 8:30 AM Flag

    Unless they buy SRPT

  • Reply to

    Wow just got FDA Apptoved at INSY

    by demapples Jul 5, 2016 8:23 AM
    bergycb bergycb Jul 5, 2016 9:09 AM Flag

    Epidiolex and sativex

  • Reply to

    Wow just got FDA Apptoved at INSY

    by demapples Jul 5, 2016 8:23 AM
    bergycb bergycb Jul 5, 2016 9:06 AM Flag

    You probably are familar with GWPH, their cannisbis based drug, epidiolex?, appears to be efficacious in key clinical trials. Opiods are way overabused. Mmj abuse cant be any worse.

  • not that long ago he put chances of AA at 15%. then after PDUFA delay and request for PROMOVI biopsies he called that concillatory by FDA and he upped AA to 45%. now this morning he has read the tea leaves on the changes to ESSENCE, he seems to be predicting AA will happen in 3Q16, so he has upped his odds for approval yet again, of course all assuming ESSENCE biopsies show stat sig increase in D

  • Reply to

    % Percent of Normal....

    by bionerd51 Jun 7, 2016 4:42 PM
    bergycb bergycb Jun 9, 2016 11:22 PM Flag

    And i admit, a threshold for fold increase may not be the correct way to look at it. Obviously a simpler way of looking at it: is systemic rescue of dystrophin taking place? Will be interesting to see how the fda defines that. But i dont know how you set 1%, 3%, 10% as the threshold for systemic rescue of D. It seems to me it will be a function of fold increase......we shall see

  • Reply to

    % Percent of Normal....

    by bionerd51 Jun 7, 2016 4:42 PM
    bergycb bergycb Jun 9, 2016 10:54 PM Flag

    Stat significant fold increase of D from an adequate and well controlled study that is

  • Reply to

    % Percent of Normal....

    by bionerd51 Jun 7, 2016 4:42 PM
    bergycb bergycb Jun 9, 2016 10:52 PM Flag

    You make many good points but Janneys Debjit in a note today claimed that SRPT management has told him that the fda has asked for PROMOVI WB D data but has not asked for PROMOVI 6 MWT data. Now either debjit or srpt could be full of it, but if they are correct then the fda is not looking for correlation between D and 6 MWT as a threshold for AA as you suggest. If that is the case AA all comes down to what is good enough D data for fda? Is it 1%, is it 3% etc? Or is it fold increase? Since srpt has proven exon skipping, mRNA production, increased D + fibers in animal andor human models AND you combine that with Woodcocks quote:
    "there is agreement that the drug does achieve primary pharmacodynamic effect," and i really believe a stat. significant fold increase over baseline is what JW is looking for. We shall see

  • Reply to

    Really? 37.5 Million

    by lender959 Jun 9, 2016 8:16 PM
    bergycb bergycb Jun 9, 2016 8:32 PM Flag

    Cpxx 2 months ago raised 40 mill$ at 9.5, just got bought out for 30. The people who got in on that secondary did pretty well

  • Reply to

    Janney's Debjit claims that SRPT

    by bergycb Jun 9, 2016 3:35 PM
    bergycb bergycb Jun 9, 2016 3:47 PM Flag

    I dont know, he got really bearish until today for a few weeks. I agree he is clearly one of the better analysts but he needs to weigh the entirety of the data and think more independently about that data. Its all just a game to these guys

  • Reply to

    Is it this simple? JWs quote:

    by bergycb Jun 9, 2016 12:00 PM
    bergycb bergycb Jun 9, 2016 3:37 PM Flag

    Did you see Debjits note? I have been wondering about the correlation he mentions. I think he quotes srpt management. If this is true it s huge

  • "Management remains confident on the likely mechanistic validation of eteplirsen, especially since the agency is not asking for a correlation with 6MWT. "
    If this is true, what management claims, this is very very bullish imo

  • Reply to

    Is it this simple? JWs quote:

    by bergycb Jun 9, 2016 12:00 PM
    bergycb bergycb Jun 9, 2016 12:07 PM Flag

    Contd, its pretty clear, unlike most of the most extreme bears, JW does not appear to believe etep is a placebo or sugar pill. Bears should keep that in mind

  • "there is agreement that the drug does achieve primary pharmacodynamic effect," imo this was a tip of the hat to the DMD experts letter and open hearing testimony. The problem is you cant approve a drug on a letter as sufficient data obviously. Add to that 201/202 was determined by adcom panel , in a close 6-7 vote, not to be adequate and well controlled. But it seems clear to me the D data in PROMOVI was collected in an adequate and well controlled manner. Just compare and contrast the D methods in 201/202 to PROMOVI, its quite stark. So once JWs quote can be verified by an adequate and well controlled study, will these boys finally see AA??

  • Reply to

    I see two things from this

    by bergycb Jun 8, 2016 7:32 PM
    bergycb bergycb Jun 8, 2016 7:36 PM Flag

    Contd if they werent slightly unsure of something they easily could have waited til after AA. Lets see the D data , it better (and imo should) be good

  • 1) SRPT is confident in AA, otherwise they would be asking for more but 2) they are unsure of something: either they do not know yet exact WB dystrophin #s or they dont know exactly how fda will react to that data. Nothing has changed in my mind from yesterday: ie SRPT can get AA but they have to produce the data

  • Reply to

    $ 50.00 / share @ 750,000 shares = $ 37.5 M

    by odetotoritori Jun 8, 2016 7:09 PM
    bergycb bergycb Jun 8, 2016 7:28 PM Flag

    I dont believe so, in the sec filing they list approx 1.9 mill shares being offered

  • Reply to

    the plot thickens, but why now?

    by wildwillyyy Jun 8, 2016 4:43 PM
    bergycb bergycb Jun 8, 2016 4:48 PM Flag

    Details on price are very important, but my guess is some institutional investor is going to make a ton of money or lose a ton of money.....hmmmmmm......

  • bergycb bergycb Jun 8, 2016 10:53 AM Flag

    Heres from his twit longer, good stuff from adcom:

    no votes on the AA question and their post-voting commentary.

    ---Glen Nuckolls, PhD: Mentions different patients, different muscles, “and I don’t find that this fits the definition of an adequate and well-controlled study.”

    ---Caleb Alexander MD and professor of Epidemiology and Medicine: “I had concerns about the techniques,whereby dystrophin was measured, the relatively modest or very modest absolute amounts of dystrophin produced, as well as the absence of more scientifically rigorous selection and management of controls to allow for what I felt would be comparisons that would lead me to be more confident.”

    ---Dr. Richard Kryscio (Biostats Professor): “I don’t think the studies were well-controlled…using different tissue samples…” “I was concerned about lack of correlation…” between dystrophin levels and substantial clinical benefit in individual patients.

    ---Dr. Onyike: "The questions [regarding accelerated approval and standard approval] twice mention well controlled and as you’ve heard repeatedly people have said that they had trouble with the controls so this well controlled phrase in a sense tips or constrains the question."

    ---Aaron Kesselheim MD (Division of pharmacoepidemiology and pharmacoeconomics): He divided question into 4 parts. “For me the induces production part was the easiest. It clearly does seem to me to induce production.” “studies that were provided by the applicant were not adequate and well-controlled” And again he is also bothered by lack of “correlation” between clinical outcome (acknowledged walking benefit just as Kryscio did) and numerical levels of dystrophin in each indiv. patient’s case who did seem to benefit.

    Interesting stuff

  • bergycb bergycb Jun 8, 2016 10:49 AM Flag

    You are correct, we dont know what the results will be. But there is little reason to expect they will be much different than the data from 201/202. As far as i can tell, in terms of the adcom vote on AA it was 6-7. And many of those 7 who voted against stated they thought D was being produced but cited lack of adequate and well controlled studies for why they voted no. Promovi data will be adequate and well controlled. Aftter that its difficult to predict what dunn, woodcock, califf et al will do . But mad scientist on twitter wrote up a great summary of the adcom panelists quotes on the D data and their vote on AA. Beyond his turrets syndrome, its a good read.

4.32+0.01(+0.23%)Jul 22 3:58 PMEDT