Thursday, February 24, 2022 3:30:13 PM
Couple of insights from a phone conversation with DI today, I know its not much but will share anyway.
1) Look for Annual 10-K first before ASM which means April/May. Not sure if Virtual or in person, seems he indicates they want 10K out first so discussion is current
2) Implied confidence of world using real world data RWD and RWE Real World Evidence and not Placebo for trial data
Link from FDA 2/1/22 (not from DI but from myself)
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
3) Parallel work going on while waiting for manuscript peer review and publication, multiple behind the scenes tasks being worked on to expediate approval for DCVAX, the goal is approval not just TLD
He did not say manuscript peer review was hold up but that was IMO what he implied. Seems a lot of work going for the approval process while we wait for TLD
4) Spoke about how overall market especially BIO's taking a beating so not surprised of the SP for NWBO, although no negative news has been provided to warrant current SP Understands some have now lost their patience but everyone has to do what is best for them based on their on financial circumstance. He reiterated the patience of investors to allow NWBO to get everything right, that they feel their plan is the best way forward pre TLD and approval
1) Look for Annual 10-K first before ASM which means April/May. Not sure if Virtual or in person, seems he indicates they want 10K out first so discussion is current
2) Implied confidence of world using real world data RWD and RWE Real World Evidence and not Placebo for trial data
Link from FDA 2/1/22 (not from DI but from myself)
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
3) Parallel work going on while waiting for manuscript peer review and publication, multiple behind the scenes tasks being worked on to expediate approval for DCVAX, the goal is approval not just TLD
He did not say manuscript peer review was hold up but that was IMO what he implied. Seems a lot of work going for the approval process while we wait for TLD
4) Spoke about how overall market especially BIO's taking a beating so not surprised of the SP for NWBO, although no negative news has been provided to warrant current SP Understands some have now lost their patience but everyone has to do what is best for them based on their on financial circumstance. He reiterated the patience of investors to allow NWBO to get everything right, that they feel their plan is the best way forward pre TLD and approval
Recent NWBO News
- Form 8-K - Current report • Edgar (US Regulatory) • 04/07/2026 04:30:50 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) • 03/31/2026 09:04:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2026 10:14:59 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/26/2025 05:15:34 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2025 09:26:03 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/19/2025 09:15:48 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
