. . . I think, mt, that without the sympathy votes that were cast due to emotional blackmail, the end result would have been a near-unanimous rejection of etep . . . bottom line: oliglops are flops . . . and it seems every big pharma knows it . . .
. . . what's more, can you imagine how negative the vote tallies would have been had those sick kids and their families not been in attendance? . . . without the sympathy votes, it likely would have been much closer to a unanimous rejection on all counts. . .
. . . will srpt do what the CRL tells them to do to move etep forward? . . . or will they go for a political end-around? . . . since the drug -- according to the FDA and its panel of experts -- appears to be a flop, my bet is on the latter . . .
. . . can't wait, g3, to see your updated numbers on this after today's adcom . . .
. . . she knew how important this panel was to the unprecedented number of patients, family members and other stakeholders in attendance and made a personal commitment to attend . . . her remarks seemed both concise and conciliatory to the families, while also giving every opportunity through timely clarifications to the panel members to ensure a fair hearing for etep . . . that said, Dr. Woodcock is a consummate professional . . . she serves as Director of the Center for Drug Evaluation and Research at the FDA and previously served as Chief Medical Officer of the FDA since January 2007. . . but now the crazies here on this board talk as if she is going to take the hard-working members of own her staff and those outside experts who had to take those tough votes today and throw them all under the bus? . . . why? . . . do you think she has so little integrity that she would buckle under political pressure to single-handedly approve a drug that can't prove its worth? . . . I don’t think so . . . she's not some political appointee out to save her own skin . . . she's there to do a tough job -- and do it well . . . just sayin’ . . .
. . . keep in mind, d1, that FDA communications, for the most part, are confidential, due to the proprietary information they often include . . . so, it is the sole responsibility of the drug company to transparently communicate with its investors and other interested parties on material interactions with the FDA -- for instance, when a CRL letter is issued . . . but it's not at all reasonable to expect the FDA to routinely review or police those efforts after the fact . . . just sayin'. . .
. . . o.k., cf, I'm game . . . how did they choose just 12 kids and not cherry pick? . . .
. . . AF's comment, I think, is spot on . . . moreover, if etep wins approval, comparing 12 cherry-picked patients against a poorer-performing historical group could likely become the winning strategy for every two-bit biopharma pushing a patented snake oil . . . (long srpt -- till tomorrow)
. . . "The FDA has manipulated SRPT's share price and literally caused, ON PURPOSE, with malice...............................over a BILLION dollars of losses" . . . gotta hand it to you, g3, you uberpumpers know no bounds . . . but keep the laughs coming, it's the only reason folks follow this board . . . (long srpt -- till tomorrow) . . .
. . . the job of the FDA is tough enough . . . without people who gamble on speculative stocks questioning their principles and motivations . . .
. . . I think that if the etep supporters are smart, they won't try to bully the panel or overwhelm them with emotional repetition . . . in fact, I think extending the public comment period and putting such a bright spotlight on the proceedings may only serve to stiffen the objective resolve of the panelists -- whatever that might be . . . that said, I do remember the highly public FDA review of tysabri -- an absolute wonder drug for remitting muscular sclerosis -- after it had been pulled from the market, following a couple of cases of progressive multifocal leukoencephalopathy which typically results in severe disability or death . . . testimonials turned the tide that day when some patients -- who were literally freed from their wheelchairs after taking the drug -- told the FDA that they would rather take their chances with PML than live without the drug . . . the FDA responded by reinstating tysabri -- which was a first for the agency . . . unfortunately, etep -- from a performance standpoint -- is no tysabri . . .
. . . it's not about what I "believe", m1, but what I've learned from being a long-time biotech investor . . . one, if etep had delivered truly meaningful efficacy without side effects, the drug would already be on the market on a conditional basis . . . two, the FDA's independent panel of experts have a really tough job to do: they are there to review the data in an unemotional way and provide an objective assessment of what they actually see -- not what they might hope to see . . . the "36 experts," on the other hand, while no doubt fine folks, have nothing to lose with their endorsement . . . think about it -- if the adcom panel votes to recommend etep, their superior insight is validated . . . if the vote doesn't go their way, they're seen as heroes standing up for sick kids against a heartless bureaucracy . . . in my opinion, the right thing would have been for srpt to grant as many patients as possible the opportunity to participate in the current study – at their own expense, if need be -- under the compassionate care/expanded access program sanctioned by the FDA . . . but I think I read that srpt said . . . no . . . (long srpt – for the very short-term) . . .
. . . obviously, m1, this is your first trip to the rodeo . . . it's the actual vote counts that matter . . . a unanimously favorable vote on every question is ideal and would likely result in your best share prices on Tuesday . . . but if the vote count is mixed -- or worse, only a tepid endorsement, then all bets are off . . . because, it's not over until the FDA approves etep and signs off on a label, and the "conditions" of the accelerated approval are known . . .
. . . spot on, mg . . . and I would add that if, in May, the FDA caves in to outside pressure, they'll be opening a Pandora's box, wherein every two-bit bio/pharma with a useless drug will press for accelerated approval based on marginal results from a small group of cherry-picked patients . . . and why not, if a precedent is set?. . . that said, I don't think the FDA will buckle, but I'm betting -- with a small trading position -- that the adcom panel, under pressure, will give a mixed thumbs-up that results in a share price gain that I can cash out on Tuesday . . . best of luck . . .
. . . "In other words, the FDA acquiesced to a study it does not know if it will believe because of pressure created by public statements by Sarepta, by FDA officials own meetings with patient advocates, and by the fact that Sarepta’s statements on its meetings with the FDA went publicly uncorrected. . . . By law, the FDA’s communications with companies are considered privileged, and the FDA is limited in what it can say about those deliberations." . . .
. . . oliglops are not a one-time genetic cure . . . wake up . . . and read . . . good luck . . .
. . . I'm betting on a mixed, but slightly positive, adcom vote, ke, but I think any reasonable person -- without a vested financial interest -- can see that the performance of this drug pretty much stinks . . . more important, potential genetic cures from at least two academic labs -- Duke University and the University of Missouri -- appear to be taking shape following breakthrough results in recently completed animal studies . . . sure, it will take many more months before the first humans are dosed, but if these one-time treatments work as expected, the results will also be known in a matter of months -- not years . . . that's why Novartis, Pfizer, Bristol Myers, Biogen and so many more big pharmas are already partnered with genetic engineering outfits like Bluebird . . . "What company or researcher in their right mind will try to work in this area after this?", you ask . . . following a true genetic cure breakthrough, I would think, no one . . .