harry that would be on the filings
they were all open market direct purchases and not option related
ONE LAST POINT FOR THE INSANE ASYLUM
what do you think the stock would have done yesterday if the market generally believed that the srpt insiders bought on direct non public material info, such as new trial data?
THE STOCK WOULD HAVE TRADED 10,000,000+ SHARES AND HAVE BEEN AT 25!!!!!!!!!!!
experienced market participants know the buys were bullish, but they do not assign "tangible material bullish knowledge" to the buys!
you probably had a million shares of retail in the initial run-up, and some retail short covering
no big players saw the buys and said "wow super data is definitely out" and I need to buy in front of it
again, the volume would have been 10 million shares
OF COURSE THEY ALL BOUGHT AT THE SAME TIME
the lawyers determined the insider buy/sell window was open because there was no material info in house at the moment
the company is likely expecting to hear from the fda soon, so if anybody wanted to buy or sell, they had to hit the window before the info flow with fda starts up again
have you not ever noticed that with all real public companies, the insider transactions are always around the same tight time frame?!!!!!!! do you think that is coincidence?!!!!!!!!!!
IT IS BECAUSE THE LAWYERS DETERMINED THE BUY/SELL WINDOW IS OPEN!!!!!!!!
you have all of this exactly backwards
your theory is an invite for those buying directors to have a front row seat in the "big house" for a reasonable period of time
the odds of rick barry, especially, doing that are about zero
they bought on a level field
their buys were very bullish
but they did not openly violate basic BOD SEC guidelines
this is not some penny stock run by bucket shops
the public forum exposure of their actions would be non stop if material trial data was dropped right after their buys ... the shorts would have a field day
you say nobody would complain? now that, is more insane than what gary said
it would be all over yahoo, twitter and investor village, and would find its way directly to theh SEC
those buying directors and their lawyers all know this, and they would never take such risk, not ever
your post is insane
if srpt had any new material trial data ready for release, good or bad, no director could transact in the stock until such data was publicly disclosed
and it is highly unlikely at this point that any such data would be deemed not material
I assure you that not one of those buying directors took any measurable risk with their purchases
they bought on a playing field they and the srpt lawyers deem level
do directors have a generally advantaged view? of course
but do not confuse that with buying on non disclosed trial data
that they bought is obviously bullish for all obvious reasons
that is good enough without getting crazy about them buying on material info they and not you have
those insiders who bought will not be a position to sell until after the PDUFA date, due to insider trade windows in and around earnings
thus, they bought for FDA approval, and not just an adcom trade
It is the opposite
The insider buys prove out that company has not received any non public material info from FDA
Revised briefing docs would be mega material
What those buys do show is director CONFIDENCE
as I have previously stated, I believe the FDA's voluntary act of deeming the 4-year data to be a material amendment to the NDA, to be a materially bullish event in the analysis of whether etep could ever be FDA approved
the FDA had etep DOA on those briefing docs
it was done, and all FDA had to do was play the clock out
instead, it made a totally discretionary move to add 90 days on to the process that I am sure the FDA views as pure torture
WHY would it do that?
I theorize that somebody at the FDA, somebody with power, said " we can never change our mind in the context of admitting we were wrong, so instead, we will declare a do over based on after acquired facts"!
whether that senior FDA person who played that card can prevail against the OBVIOUS etep haters at FDA, remains to be seen
etep was dead, but now it has a flickering heartbeat
next signal is the adcom questions
anecdotal evidence means zilch, and less than zilch if the adcom questions do not contrain an approval vote
FDA will either hang its hat on the 4 year data as an a material inflexion point, or not
in other words, FDA can blame pre 4-year alleged benefit on placebo, steroids, and cherry picked control group ... BUT at 4 years, FDA can no longer ignore the benefit (changing your mind without changing it ...)
this post has been approved by tred, whether he knows it or not
you are speaking of the risks of the drug administration
I am speaking of the risks of assuming the fda will give a rat's bottom about that anecdotal evidence when making its determinations on etep
the reason you do not see this is because you are an expert on keeping your blinders perfectly positioned on your face
you are exactly right
my analysis is always embedded in valuing the risk/reward of the investment, and NOT what is right and/or wrong
my point today has been that using anecdotal evidence to evaluate risk/reward of this investment is lunacy
IMO, the fda has proven that in spades already
dear my friend tred
your ability to ignore obvious risks, let alone reconcile them, is legendary
and I applaud your talent to keep your blinders on your face, no matter how forceful the headwinds
you have a gift
"Tragic Patient Stories Don't Trump Weak Data, Official Says"
it is a February 26, 2016 article
here is a quote:
"Heartrending anecdotes of sick patients in need can’t overcome the shortcomings of weak drug trial data, said one of the U.S.’s top drug regulators, as outside advocacy groups seek a larger role in the drug approval process.
The Food and Drug Administration has worked to better include patients in the development of treatments after a 2012 directive from Congress. While patient support can help a drug’s chances, the key is having evidence the FDA can trust, said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research."
How dare JW say this in the face of FDASIA!
unless of course, she was just in a moment of HONESTY/REALITY
FDSIA is a sham perhaps not in legality, but definitely in reality
I did not forget how dumb doctor-like you are!
OF COURSE THE FDA WILL ALWAYS BE ABLE TO SAY IT "CONSIDERED" EVERYTHING ALL THE PATIENTS AND RELATIVES SAY!
tred, you ARE dumb
but nobody, not even you, is THAT dumb
SRPT IS A POSTER CHILD FOR FDASIA COMPLIANCE!
just ask the FDA ...
take your mindless blinders off, for the love of God (and bud)
the "news" (I use that term loosely) is months old
and it is not an fda trial approved clinical data point
it is anecdotal evidence (I use that term loosely) and is arguably worthless to the FDA reviewers
I believe the FDA can use srpt/etep as a poster child for FDA compliance with certain aspects of FDASIA
the level of etep proponent access to FDA officials is unprecedented
BUT THIS HAS NOTHING TO DO WITH WHETHER THE FDA ACTUALLY CARES ABOUT A SINGLE WORD THEY SAY
FDASIA is a charade
I believe that the FDA decision makers will already know by the time of the adcom, what they will do with etep (just like they did with drisa)
in other words, the entire pile of etep anecdotal evidence is a non-impactful show, and has been for the last 3 years
do you actually think the FDA CDER director did not know what those FDA BDs said before they were released to the public? Of course she did ...
and she could still stand before Congress and say she has honored FDASIA in spades
the first reliable signal that etep may have a chance was the FDA "material additional info"
the next and likely ONLY real signal we will have here is the release of the adcom questions (no anecdotal evidence has ANY signal)
if the questions contain a "yes/no" adcom vote on approval, that will be very bullish
if not, that will (ala drisa) be very bearish
yes, the BDs could be rewritten too, but I would not even rely on that signal if there is no "yes/no" adcom vote
the FDA has played FDASIA like a fiddle with etep
I can hear JW standing before Congress expounding on all the advocate access and constant communication she personally engaged in over 4 years
the FDA will either approve of the clinical surrogate and/or end point data, or not
all the rest is noise
sad, but I am certain, true
I offer the following for consideration:
THE FDA HAS PROVEN, ARGUABLY BEYOND ANY REASONABLE OR UNREASONABLE DOUBT, THAT IT ASSIGNS ZERO VALUE TO ANY FORM OF ANECDOTAL EVIDENCE
I do not believe that anything to be said by anybody at the adcom will actually influence the FDA folks
they might influence the adcom members, but ultimately, not the FDA
if my theory is right, there will be NO adcom question asking for a vote on approving the drug
conversely, look out above on srpt stock price near term, if pre adcom, the adcom briefing docs contain such a question
I say this because I believe the market will assign great meaning to the inclusion of such question
in comparison, no such question was presented to the drisa adcom, because it was clear the FDA had already decided to kill that drug before the adcom even met