Tuesday, June 07, 2022 5:54:50 PM
May be or not, but resurfacing TBD clues and timeline hints that possibly a BLA has already been filed and approval is closer than we think:
A start time?
- Q3'20 10Q disclosed NWBO entered into agreements to prepare "potential applications for regulatory approvals of the DCVax-L product."
- Oct'20 the trial's data was locked
- Oct'20 the SAP was updated in the EU registry
6 months later, a BLA completed?
- Apr & May'21 Linda Liau gave presentations discussed a contemporaneous control database and how the ECA would be used in statistical analyses.
6 months later, a clue of tentative approvals with FDA?
(Pharmaceutical ad laws and regs do not allow drugs, not yet approved, to be advertised to doctors, except under preapproved premarket promotion programs.)
- Sep 2021: an ABTA full page ad shows DCVax(r) (product name) and Immune Therapies (marketing claim)
- Nov 2021: a SNO tote bag was given at a professional conference for oncologist, showing again DCVax(r) (product name) and Immune Therapies (marketing claim)
6 months later, a clue that we are waiting for approval, not a BLA filing?
- May'22 clinicaltrials.gov was updated with the revised SAP, maybe a change in status with the FDA, a signal of completion in the tentative status it had with "premarket promotion"
- May’22 Iwasadiver, Post# 482729
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- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- 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
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
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