the entirety of yesterday's events, if reduced to one word, would be "uncovered"
that single word evidenced, as we in the trade like to call it, "malice aforethought"
it is my understanding that the FDA has yet to offer a single word of explanation on that
IMO, that one word was probably responsible for at least 50% of the market cap reduction yesterday
did the FDA think that was a good word to use when it is encouraging the company to convince parents to do a 4th biopsy?
something is very very very very wrong here when we see the FDA engaging in gamesmanship in its guidance
read the april fda guide
the fda guide assumed a compromise where the fda would "appear" to acting off the P2, but in reality, would have a significant amount of new data from new trials that the ceo clearly repeatedly publicly guided at that time would be starting in july 2014
the fda reviewers thought they would have at least 9mth to a year of data by time the 12/31 filed nda got to fda for decision in mid 2015 to Q3 2015
but srpt blew all the trial dates by months and months since last spring's company guide
with the way these fda underlings clearly view cg and maybe the entire company, they shoved it up his buttocks when he assumed they would keep their schedule, while he delayed ALL of his schedules to the point that they would not have most of the data they thought they would have by mid 2015
its a mess, on both sides
cg is not completely clean on this in my view
and the fda folks involved are likely gunna get their own returned favor by time its all played out
I hope that there are more job opening wherever bastings now is in the fda building
I agree 100%
simp08801 and np32817 are spelled differently
so of course we are different people, this is obvious!
this would be like me somehow suggesting that you, johnny8778, are the same person as giventotweet on twitter
my dog, and I bet your dog, know those names are spelled differently
I cannot believe how many poor spellers we have on these message boards!
personally, I am just wunderin if the cder director is going to reconcile this mess
cuz I am sure she is being formally asked to act fairly and clarify exactly what happened here
and it is a mess, a big mess
IMO, I am not sure how the fda cder director can escape this fact in silence
read her July 2014 public letter written as a response to the 100,000 signature effort, which contained MANY express supportive comments about Srpt
and ask yourself this
IF, AT ITS MAY 2014 SITE VISIT, THE FDA REVIEWERS “UNCOVERED MARKED DISCREPANCIES” IN CERTAIN ASPECTS OF THE SRPT DYSTROPHIN DATA, HOW COULD WOODCOCK POSSIBLY WRITE THAT SPECIFIC RESPONSE IN JULY?
was she totally unaware of such "uncovered marked discrepancies"
she will have to decide which applies:
1. she was made to be a complete fool by her direct underlings who are still seething over bastings' being re-assigned over sprt related terrible behavior
2. she was deceitful in her July 2014 letter
either one is bad, and DEFIES, logic, and good faith behavior
What is the fastest, most efficient way for the FDA to immediately remove a drug candidate from the regulatory approval train track?
1. declare all train travel unconstitutional
2. put Amtrak in charge of the train schedule and operations
3. issue a statement to company on 10/25/14 that it knows (or at least should know) the involved drug company will have to make public, without advance warning, or explanation, that you have "uncovered marked discrepancies" in what is commonly assumed to be the MOST important underlying data point relating to the drug candidate
IF the actual, God/Bud approved FACT proves to be that prior to 10/25/14, the fda reviewers never uttered a sound about their miraculous discovery, in early May 2014, to ANYBODY at the hospital or the company, then, IMO, the ramifications of this situation will dwarf those that occurred in April 2014, when bastings got "relocated" to another division
this is actually much worse than the November-April situation
that it happened once is crazy
that is impossible to reconcile
but the CEO's repeated delays in the P3 schedules set the company up for this to a degree
even without the "uncovered marked discrepancies", he handed the FDA folks the following defendable excuse:
"when we (FDA) told you (Srpt) we would accept an NDA filing by 2014 year end, you led us to believe that by that time, you would have all the new trials we discussed in dosing mode, for quite some time, but now, you have NONE going, after repeated delays, and we are no longer sure we can trust you will actually get them going any time soon, thus, if you can delay, so can we, and if you are looking to blame somebody for our delay, get a mirror, because you are not the only player in this game that can unilaterally change its underlying assumptions"
before I give my "FDA Response for Dummies" summary, it is critical to acknowledge what the FDA did NOT address ...
the FDA did not touch, even with a word, the issue of whether anything regarding the infamous FDA words "uncovered marked discrepancies" was EVER communicated in any way, to anybody, prior to the issuance of the 10/25ish FDA minutes
I AM CERTAIN THAT IF THE FDA HAD DONE SO, IT WOULD HAVE BEEN IN THE LETTER ...
also, and equally importantly, the FDA did not touch what those words meant, and that should be a huge signal that the CDER Director has yet to figure out WHAT THAT MEANT AND WHY IT WAS WRITTEN BY HER STAFF
FDA IS UNCLEAN ON THIS ISSUE, AND IT KNOWS IT
having said this, the FDA was "brilliant" in its response otherwise, as it has depicted itself as a largely ignored regulator where the applicant has simply refused to follow its clear lead, repeatedly (count how many times the words "consistent" and "consistently" were used by FDA describing how it has behaved)
brilliant, cuz the FDA knows the applicant cannot ever come back and say the FDA is wrong about anything it said
game set match FDA over the MUST BE NOW FIRED SRPT CEO
now for the summary:
1. we, the FDA will not touch any issue we are guilty on, not now, not ever, so don't hold your breath
2. We have given the applicant clear and perfectly consistent messages on what it needs to do, and when, and the applicant has wholly failed to do same, but we, the FDA, are here for the applicant if and when it ever does same
3. There was no applicant fraud, we admit that, but do not expect us to tell anybody exactly what we meant when we said "uncovered marked discrepancies", because frankly, that is one of our "soft spots", but we will eventually tell you after we make it up
the summary is now completed
my final thoughts
THE CEO MUST GO
IMO, he clearly has a horrific relationship with the FDA, as that letter was a thinly veiled direct attack on the applicants failures in the process
one more thing
the FDA did learn something from its prior "mistakes" (outright lies ... remember its concern over RNA data it later had to admit it did not even have? ...)
the FDA knew that it could not let this issue fester for longer than one day
it got bombarded by the dmd folks, and it immediately responded
and it knows they can't now say, hey thanks, but we need you to do another response and say more stuff we want to hear
the FDA effectively snuffed the issue, right quick
and all that is now left is the thought that the company has largely failed to honor the regulator's request, but that notwithstanding, the regulator is prepared to act quickly, if the company every gets its own act together
it was, brilliant
and the FDA knows the Srpt BOD cannot now issue its own attack on the FDA for the FDA's soft spots
everybody got snuffed
there is only one thing the Srpt BOD can now do that matters
FIND SENIOR PEOPLE TO BRING IN WHO HAVE RELATIONSHIPS AT FDA
that would be worth its weight in gold, especially after that FDA letter
its not about "blame" or "right and wrong"
its about reality
clear your head and ask yourself the following question
DO YOU BELIEVE THAT THE FDA WOULD ISSUE THAT RESPONSE IF HE HAD ANY MEANINGFUL, POSITIVE RELATIONSHIP WITH THE CEO?
I say of course not
The FDA skewered him
the company can never win this "war" with the FDA
IMO, it must show faces to faces to the FDA that are new to Srpt, but not new to the FDA
and its bigger than that, the CEO's decision to take Mendell and his hospital over Hoffman and his hospital could turn out to be the biggest mistake of them all
where would Srpt be right now, if Hoffman was the chief trial investigator?
life is not fair
and it appears huge mistakes were made here by the CEO
they are tied to the "168 week" walk tests as to timing, which has now made those tests "168 to 173 week" tests
we will not see anything on those biopsies until early 2015
CG knew the fda wanted this 10 (TEN) months ago
all objective observers know why
THE FDA REVIEWERS ENGAGED IN BIASED BAD BEHAVIOR, perhaps because they say their friend bastings get his career whacked over a company attempting to AA on an n=10
but the management's repeated delays in P3 and other progress since April handed them the perfect "good government excuse"
and they waited for the perfect moment and cashed that chip in
which chip was designed, manufactured and delivered, in a perfect wrapper, to the FDA by the Srpt CEO
IMO, I do not see how he can survive it, in terms of remaining the lead architect and face person on future FDA dealings
the company needs to spend BIG and FAST on a known gray hair who the FDA knows and respects
and if that person comes in and determines that certain underlings need to be replaced, the CEO cannot be allowed to interfere
we have chose to ignore it, but the CEO has now hired 3 very senior people, drowned them in options, and paid them well, which normally engenders loyalty
but in his case
two abruptly left without fanfare after less than a year
and the other tried to have him killed
THEY WERE HIS HIRES
he cannot be near the FDA, starting now
surely that FDA response was written at least in part by the CDER director
and it is alleged she is essentially his ONLY fda friend
and that response was still sent in the form of a direct swipe at him
there must be immediate change
I will be very worried if there is none, in terms of future prospects
As of now
Only 4 are recruiting
Today is November 1
Compare this to ceo's latest delayed guide on new trial start dates
The signals were there
He said they were recruiting a while back
But the trials were not even yet posted when he said it
He appears to have been leading with his tongue when he first said they were recruiting