. . . I'll assume it's your first time to the rodeo, f7 . . . if the FDA is going to reject on this round, it will issue a complete response letter . . . this CRL will detail what srpt has to do to keep etep moving forward . . . if jw is going to throw srpt a bone -- imo -- it will happen in that rejection letter, perhaps by providing another date-certain review, say in 12 months . . . that would at least give the FDA's patient-performance-decline charts more time to play out . . . if etep patients show improving performance, then it would likely win accelerated approval . . . if not, then . . . well . . .
. . . if you believe that jw is going to throw her staff and her panel of outside experts under the bus and unilaterally approve etep . . . then you may be on to something . . . why would she wait? . . . just sayin' . . .
. . . no, mr . . . sold the last of the BMRN back when, and just recently bought back into srpt (4th time) with a trading position, pre-adcom, at $13 and change, which I still hold . . .
. . . the better question, g3, is where is the update on your big FDA conspiracy diatribe?: you wrote, "BILLIONS in losses caused by blatant FDA manipulation" . . . "Who can forget their first multi-hundred million dollar manipulation, when . . . (blah, blah, blah) . . . Total loss, many hundreds of millions. . . . Next, they then took two years to . . . (blah, blah, blah) . . . Total losses, oh go figure, hundreds of millions." . . . "then, recently , the FDA was back to their illegal, but somehow still not punishable, blatant stock manipulation when they , with malice . . . (blah, blah, blah) . . . Total loss again, hundreds of millions.." . . . "And more recently . . . (blah, blah, blah) . . . they . . . (blah, blah, blah) . . . "Total loss...................once again, the FDA's target was hit, and again, it was HUNDREDS OF MILLIONS" . . . and on you went, but my question is, have we -- in your imaginary world -- reached a $TRILLION in losses yet? . . . (thanks in advance for running the new numbers) . . .
. . . agree, mg . . . though as a longtime biotech investor, I would really hate to see folks at the FDA cave in to emotional or political blackmail . . . that said, I don't think they will . . . but I could foresee jw softening the terms of a CRL so that etep gets another serious look in, say, 12 months . . .
. . . well, I guess if its performance really does stink -- like the FDA seemed to imply -- then I'd have to say . . . probably not . . . but I'm just speculatin' . . .
. . . you were "surprised?" . . . were you asleep? . . . by your reasoning, the FDA should sanction a high-cost placebo for every known deadly childhood disease . . . I'm good with that, actually -- so long as its cost comes out of the pockets of patients and their families . . . or good-hearted folks like yourself . . . just sayin' . . .
. . . "The panel was a set of clown with no statistical common sense" . . . said the man, who, by comparison, likely has near-zero technical expertise in the area discussed, yet probably has a large vested interest in a positive outcome by virtue of owning the company's stock . . . am I wrong? . . .
. . . could, in fact, be a great headline if this drug gets the nod . . . but why would it? . . . the FDA staffers said it looks like a flop . . . a majority of the expert adcom panel said it looks like a flop . . . oh, but I forgot -- it's completely safe to use, and it won't hardly cost patients or the health care system a thing . . . I mean, really, how high a price can you put on a placebo? . . .
. . . right, r7 . . . who needs the FDA? . . . though its rigorous standards did prevent thalidomide, for instance, from being sold in the U.S. while it was widely adopted in other countries . . . as for selling drugs that offer little, if any, benefit but have clean safety profile, there are always remedies like that available to those willing to travel outside the country in a last-ditch effort to treat a dire illness -- just don't expect your insurance company to cover the cost . . . you think maybe srpt will move its franchise to Mexico? . . .
. . . 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’ . . .