I am a mindless stock monkey
and different people define "binary" different ways
for example, my buddy copp appears to include bio rhythums in his definition
but since you asked
I do consider the impending data releases to be "binary"
1. the information in clinical information that appears to be the exact type the FDA has been gyrating over for the the past 2 years
2. the filing of the nda was a procedural matter, although its filing does speak to the substance of the application
3. there can be no confusion that given the FDA's publicly displayed 2-year consternation over dystrophin, that the dystrophin related impending data will likely directly impact directly on the fda staff write up for adcom
4. the impending data may be the last data to be released for 2015
it got binary written all over it for me
and IMO, the stock price will move big up or down off it, depending upon how it is perceived
today is september 1
if impending srpt clinical data to be publicly released by october 1 is good, I believe there will be fireworks here regardless of macro market
data will inform market as to projected adcom outcome
and IMO you have strong reason to believe that all such data is at least decent
if you seriously believe zixi is "milking a dead cow", I encourage you to immediately report this to the USDA and FDA !
and I am stopping my weekly receipt of zixmilk deliveries!
my dear devil
one must adapt one's views as new information emerges
the b 4 was not available
now it is
it is no different that when originally said your ability to shuffle board aliases was spectacular
based on new info, I am revising that to super duper spectacular!
next up, 192 week data
using timelines for the last 3 weekly data releases as a guide, it appears the 192 week data could have been publicly released up to 37 days ago
what would srpt do with such data and when?
first, lets assume the data was at least decent
what do you think the odds are that srpt would give that good data to FDA before it knew for sure that the FDA would accept the srpt nda for filing?
I say 100%, with a margin of error of ZERO
conversely, lets assume the data was bad
what do you think the odds are that srpt would hide such bad data from the FDA before the FDA accepted the srpt nda for filing, only to then drop the bad data on the FDA after the FDA filed the nda?
I say ZERO % (especially with ed kay in charge), with a margin of error of ZERO
so at this point, it seems megla reasonable to me that the FDA had both the d recount and 192 week data prior to filing the srpt nda
next up, the b4 data
I am so tired of carrying al these dumb doctors on my back, step by step, without even a single offer of a free 714 scrip
but I digress
I believe all who follows srpt know the impending srpt data releases on 10/1 at WMS will DIRECTLY inform srpt's future more than anything else on the horizon
and such potential data points are b4/d recount/192 week data
well guess what?
I believe there is compelling reason to believe THE FD HAD ALL THOSE DATA POINTS BEFORE IT APPROVED THE SRPT NDA FOR FILING
and I highly doubt the FDA would have filed that nda if any of SUCH data points were bad
which means our short friends are FFFFFF'd already whether they know it not
first up ... the d recount data
see this May 7 quote from Srpt CEO call transcript (yes, waaay back on May 7)
"So if you – you know I think probably the best way to frame this is typically for a confirmatory phase III trial if you are using an end point such as dystrophin and some of the things that I’ve done in the past is usually we’ll have three independent pathologist who will read the sample and then come to agreement on the data. So what was done in our 202 study is that was one site with one pathologist. And typically the FDA does not like only one person reviewing the data they want conformation by at least two other sources. So what we have done is we’ve used the same images that were read by national wide children’s hospital, but they have been mixed and blinded and then along with other samples, so we have pre and post the samples that are blinded and some of the same samples were reread, turned to 180 degrees and reread and so the three pathologist then read the samples, we looked at concordance among the read and then also looking at the basically what the outcome was. So all of that data is completed and will be presented to the FDA."
that was May 7, over 3.5 months ago
so what are the odds that this data was given to FDA before August 25?
I say 100%, with a margin of error of ZERO
you want to consider embracing the inner beauty of our Beloved Pearsby's posts
you may then realize that she is a shinning light in a sea of heart wrenching and insulting postings
Srpt presents at WMS on October 1
CEO publicly stated that new clinical data will be released at such presentation
such data can include all or some of the following: b4, d recount 192 w 6mwt
poster boards will be provided to WMS at some point
but safe assumption is that nothing will be public until srpt issues a pr either late on September 30 or early or October 1
that is 31 or 32 days (23 or 24 trading days), from now
for reasons that should be obvious to all, the caliber of such data is likely more informative of srpt's future than the fda acceptance of the srpt nda
unless of course, you drill a bit deeper and consider how long the recount and 192 data have probably been available to the company, and the related consideration of whether the FDA had at least such data when it accepted the srpt nda
the short thesis here finally becomes 100% incomprehensible to me if the new data to be publicly released by October 1 is at least decent
if I were short, I would be pondering what the FDA may have already seen when it accepted the srpt nda
robertson filed a form 4 today and just sold another 80,000 shares
all the spur loyalists are selling
you know better
think about this
what are the chances the fda had certain additional data when it determined to accept the nda?
I think we have a BIG winner here
I come on this message board this am, seeking to learn about the inner zen of dystrophin, and what do I find instead?
a series of nonsense posts about nonsense quotes
I have reviewed the Yahoo TOS and consulted with my lawyer and I believe I have a solid case for intentional infliction of emotional distress, with malice aforethought
RU, I particularly feel misled, if not, betrayed, by you
today's trading so far fosters my belief that yesterday's front end was MMs unloading stock they had accumulated
I would explain why further, but I am too hurt to type any more over the attacking posts aimed at pear today
I am not ashamed to admit it has made me cry
the thouht that there is no real net short is ridiculous and mathematically provable
but why interject reality into the discussion?
I mean after all, there we no net shorts on 10/2/12 either ...