Tuesday, June 28, 2016 6:17:49 AM
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.
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:
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/
"Think for yourselves and let others enjoy the privilege to do so, too."
-Voltaire
Recent NWBO News
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM