NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Wrt CLDX, that was a pre-BLA meeting. The result of which was FDA saying, "We need more, and have concerns over X. We advise therefore that you do not now waste the immense energy and time and resources it takes to file a BLA as we will likely issue a CRL."

Do you know how long it takes to put together and file a BLA especially? NDAs are long enough. The timeline you are trying to make fit is far too tight in all respects. Sure, you can find some $200B MC big pharma who can get one put together in 9 months, but the process can and often takes a year or longer, especially if it's a BLA instead of a NDA and especially if the company is small and strapped for cash. A rolling review relates to FDA's review of the application and not the sponsor's overall time it takes to put one together. If granted fast track, the sponsor may then submit it in "chunks" to help speed up the review time. That's what rolling review is. Priority review just cuts the time of FDA review down from 10 months to 6. NWBO did not receive fast track for DCVax-L.

Also, companies do often announce when an application is accepted for review, or the result of the pre-NDA/BLA meeting and next steps to file or not. It happens routinely.

Aug. 12, 2015-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organization.

“The opportunity to bring a new treatment option to those battling the devastating illness of Huntington disease is an important first step and an indication of our profound commitment to improving the lives of patients with this and other debilitating movement disorders,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “With this filing and an ongoing investment in HD research, Teva has further established itself as a leader in the development of treatments focusing on movement disorders.”

Their NDA was put together and submitted after they received positive data from the second of two P3 studies. The pre-NDA meeting was probably fruitful enough to give them hope there was a good enough chance FDA would approve SD-809. However they received a CRL in late May the next year almost exactly 10 months later. The drug had received BTD prior to this (never any guarantee).

Topline of the second of the two P3 studies was reported in Dec 2014. It took them 9 months to put together a NDA that had already been started previously by the company TEVA acquired. TEVA is a big pharma.

That brings up another point--sometimes when you see a BP put together a NDA very fast it's because the NDA isn't really a NDA, but a sNDA. These are supplemental NDAs, via label extension. Much shorter.

So putting it all together, it took them 9 months to submit a NDA, and 10 months for FDA to review it and then issue their decision (in this case a CRL).

But look, there are more reasons to reject the hypothesis that NWBO is working on or recently submitted a BLA. The section of FDA guidance that suggests this is possible without public disclosure also states the trial ought to continue for the OS endpoint. They halted the study significantly short of full enrollment, and one month later the CEO said:

"Um, we're currently in a phase 3 (subtle sigh, shake in voice, volume lowers), 348 patients, (again) uh, 300 or so patients have been enrolled out of the 348, we currently um are on hold for screening, (voice volume pretty low now) um but we will be um hopefully uh not too much longer um but for a bit longer on screening -- MEANWHILE, (tone changes) we have an update I have an update for you, today, NEW information (louder/brighter voice now) on the information arm patients..."

at minute 32:00 here:

Doesn't sound to me like they nailed PFS in an interim, decided that was enough to file a BLA for AA, began that process (a very long one) while the trial continued on, to the public's eye as if nothing at all had changed.

You and other NWBO longs are forcing what you want to be happening to fit. But none of that fits. You're completely wrong. And for some reason a plunge from $12.55 to just $0.55 hasn't made any of that sink in.

http://psychcentral.com/disorders/delusional-disorder-symptoms/