direct quote just issued from Race to Yes:
"The FDA has indicated it needs additional time to review the 4-year clinical effectiveness data from the natural history control submitted by Sarepta in early January. "
so there you have it
this is also quite bullish
the fda is now looking at the 4-year control data (which could yield a different conclusion than was drawn from the 3 year control data)
in this instance, the unbearable, on various levels, delay, may save etep
dear dumb doctor lobster
his should be her
THIS IS WHY YOU NEED ME
signed your faithful stock monkey doctor(ate)
as we know pdufa is pliable in both directions
check mnkd and bmrn
I would not be hoping for a rush here anymore
perhaps the adcom is not set yet because the fda wants the adcom members to receive updated BDs
I would rather see an adcom in late march with updated BDs than one now with the original BDs
PS to winter: perhaps the diff between 166 and 216 is the inflexion point where, under ANY of the cited natural histories, the boys should not be walking ... thus making the 216 even impact the view of the natural history confusion
yes I agree, hw
I am not being precise when I say "new" vs. "update"
I view this as a sane person (maybe JW) looking for a way to save face and revise direction
I am not sure the word "delay" even matters right now
the market may more view this as "likely death" (original pdufa) vs. "possible life" (extended pdufa) now
its the perfect fda excuse to issue new BDs
declare that the applicant materially amended the NDA after the BDs were issued
I really like it
surely not a guarantee, but I am convinced the door opened up again
I think srpt just re-became a high risk/high reward play, where the risk/reward thesis are more bullishly matched
the fda did not need to cite a reason for the pdufa extension, as that was obvious ... the new adcom date has not even been set yet!
thus, I read that fda statement about a major nda amendment as potentially, a signal that a sane person somewhere in the fda will use the 2016 data as the basis to issue a new set of BDs which may not be has horrific as the first
is there a possibility that the new BDs could say "we looked at 216 data and our view is the same"?
yes, but IMO, it will go the other, bullish way
"The FDA notified Sarepta that its January 8, 2016 submission of 4-year clinical effectiveness data, which included additional six minute walk test (6MWT) and loss of ambulation data compared to a historical control, has been designated as a major amendment to the NDA. "
this suggests to me that the FDA may be issuing updated BDs to Srpt
I view this as the first bullish signal I have found since the day the BDs were issued
I have called JW and told her "I THINK YOU ARE A MINDLESS, WEAK, MISLEADING BUTT SNIFFER, BUT I AM ALSO SURE YOU WERE STILL GOOD TO YOUR MOTHER AND WILL POLITELY TELL FARKAS TO LIGHTEN UP"
she seemed very responsive
that AF thinks the adcom date is February 29
further alleged that certain dmd'rs think closer to mid month
more important to me is what the adcom questions are, and we probably got a while to wait on that
you miss my point
I am NOT setting up any expectation for an update
I am setting up the expectation that there will be NO update, and what that means
I think it means that JW knew all about those BDs, and what they said
I know she has been bombarded with reports of innacuracies etc. in those BDs
if she believe even 1/4 of the complaints were accurate, not to mention the new 216 data, why would she not have an update done? (saying they are not usually done is not a good answer to me, in this specific instance)
so I ask again, if there is no update what does that mean about her involvement?
I think she knew all about those BDs when they were issued
sounds about right to me
which begs a key question:
WILL FDA ISSUE UPDATED BRIEFING DOCUMENTS REFLECTIVE OF UPDATED INFORMATION, AND MAYBE EVEN A FEW CORRECTIONS?
the answer to this question may inform the answer to the mega question:
WERE THOSE FDA BRIEFING DOCS REALLY JUST THE PROJECT OF ROGUE AND ANNOYED FDA STAFFERS DATING BACK TO 2 YEARS AGO, OF DID THEIR MANAGERS ACTUALLY KNOW OF THE CONTENTS AND SIGN OFF ON THEM?
if there are no new BDs, then what can we conclude about JW's involvement or knowledge of the original BDs?
dear dumb doctor lobster
you need to focus on things like bed pan studies analysis
leave the espionage to the stock monkeys
we might not know whether to drink out of, or wear as hats, bed pans
but we are good at espionage
you are a dumb doctor
the dates they were prepared are NOT the dates they were delivered
there is an entire process that goes on after the reviewers write their BDs
sprt got them around the 8th
what you SHOULD bre focussed on, instead of being a dumb doctor, is the issue of who reviewed them before they were released, but after they were written
the idea that these BD writers are somehow rogue and nobody above them knew what they said before they went out is NONSENSE
this is a much bigger mess than just assuming that farkas did this all by his lonesome, cuz he didn't
and remember, i am very fond of dumb doctors, just like you
and as for bio's statement that the adcom was next friday, that was not real from the moment he said it
it was a mathematical impossibility
I believe CG has sold tons of shares
he is no longer required to report his srpt trades
tons and tons
and thank the good lord he did