Nekkid said Zixi was a screaming buy at 3.30 after earnings
And he was right!
And he does this without black shoales!
All who ignored him are so sorry now
I heard a rumor you are now calling for a 5 handle on zixi
if this is true, it makes your call that zixi was a screaming buy at 3.30 even more remarkable than it already is
us mindless mullets need you on this wall
my dear devil
IMO, any trades made in Q4 and prior to the release of the etep briefing documents have ZERO directional value
we be flyin blind for the moment
yesterday's tripe ADV volume, trading patterns and then AH pr suggest the following to me
1. Srpt still has selective leaks
2. somebody(s) knew srpt was coming with a pr in the AH yesterday, but they obviously did not know what it was about, and they (incorrectly) assumed it was an adcom date announcement
3. as day wore on, continued srpt leaks eventually suggested there still was no adcom date (hence price action reversal)
more of the story
some in the market think the adcom date announcement is a big deal, big enough to triple the volume just on a blind wrong guess
but they knew there was a pr coming ...
the large march call holder who moved its calls out to april YESTERDAY, knew of the impending fda federal register notice on the new adcom BEFORE it was posted
I am glad to see that nothing has changed around here!
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
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
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 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)
"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
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
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