I don't disagree, but I also think that knowing what they had, and the survival benefit, they may actually have been working on the BLA for some time in advance of unblinding. If that were the case, on unblinding and developing all that's presented in a full data presentation, some of the BLA could be a matter of filling in the blanks in parts of the BLA.
I'm certainly no expert on BLA development, and as I said, I hope they bring in an experienced BP partner, which actually might slow them down, but could improve the quality of the submission. A year between unblinding data and BLA submission is certainly something I've seen from others, so it's not unreasonable, but I've also seen drugs approved where less than 6 months was taken after unblinding the trial. If they are unblinding soon, the goal could still be this year, and if it slips into next year they should be able to submit it in the first half, so approval before the end of the year would still be possible.
That said, I cannot tell you how many times I've seen the FDA delay drug approval on drugs everyone was certain to be approved by what I believe were stupid questions that could have been answered post approval. I'm a big believer in Phase 4's where all who get the drug report back on how it's use goes, this would include all off label use. I believe if the FDA approved drugs more easily, but let the Phase 4 data be in an open database, where no negative outcomes could be hidden under settlements with confidentiality agreements, drugs with problems, like Vioxx would become apparent far sooner. In the case of Vioxx, it's use could have been limited, and the drug could still be on the market today, but the company was greedy and the FDA's actions were punitive.
The problem with a question from the FDA is that even if it can be answered instantly, they get 6 months to evaluate the answer, and during that 6 months they may have another question that's totally unrelated, it gives them 6 months more. I've seen perfectly good drugs delayed for years by such FDA action which could all have been deferred till after approval, and a Phase 4 Trial that simply reports the outcome for each use.
Gary
Gary
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