Wednesday, June 26, 2019 5:48:36 PM
Just talked to David Innes for a long time. I only got one definitive statement from him but from this discussion I can offer better educated guesses as to what has been happening.
DI only answered one question directly. I got some hints about what was happening even when he contradicted me. I got even better guidance from him when he listened to what I was saying and at times offered a modification or an additional comment. Basically what I did was not to throw questions at him but rather offer my opinion and have him react. Based on his reactions such as contradicting me or working into a developing dialogue and then exchanging ideas I was able to navigate better. I offered my opinions rather than put him on a spot and challenge him to submit information. From the dialogue that ensued and from the tones in his voice I believe I was able to get some hints as to where we are.
Here is my takeaway.
1. Is there a soft database lock in place?
Answer: NWBO never made an official announcement that this lock as yet exists but does not exclude that it will happen in the future.
He also made no contradictory comment when I told him that I believe that as long as 100s of queries were not answered, there will not be such a lock. The soft lock seems will be more flexible than the hard lock and I am guessing that after this soft lock is reality (perhaps in the near future) periodically new results will still gain entry. I got that idea because DI emphasized that after hard lock nothing will change.
2. The mOS is of little importance, the long tail very important. Nothing new here.
3. I offered that 55-60 will be post 5 year survivors and he did not offer his opinion but did imply that if true this would bode well for the trial. I trust that he shares my belief that now there are no 80+ survivors.
4. With respect to unblinding he did not rule out September or if I recall correctly even earlier which makes me think that the SAP is about to be sent to the RAs. I did not get the impression that he believes that the SAP will constitute an unusual challenge to the RAs.
I will be very busy until late tomorrow and if there are any questions, hopefully i will be able to answer tham tomorrow. I am also expecting some vicious attacks.
DI only answered one question directly. I got some hints about what was happening even when he contradicted me. I got even better guidance from him when he listened to what I was saying and at times offered a modification or an additional comment. Basically what I did was not to throw questions at him but rather offer my opinion and have him react. Based on his reactions such as contradicting me or working into a developing dialogue and then exchanging ideas I was able to navigate better. I offered my opinions rather than put him on a spot and challenge him to submit information. From the dialogue that ensued and from the tones in his voice I believe I was able to get some hints as to where we are.
Here is my takeaway.
1. Is there a soft database lock in place?
Answer: NWBO never made an official announcement that this lock as yet exists but does not exclude that it will happen in the future.
He also made no contradictory comment when I told him that I believe that as long as 100s of queries were not answered, there will not be such a lock. The soft lock seems will be more flexible than the hard lock and I am guessing that after this soft lock is reality (perhaps in the near future) periodically new results will still gain entry. I got that idea because DI emphasized that after hard lock nothing will change.
2. The mOS is of little importance, the long tail very important. Nothing new here.
3. I offered that 55-60 will be post 5 year survivors and he did not offer his opinion but did imply that if true this would bode well for the trial. I trust that he shares my belief that now there are no 80+ survivors.
4. With respect to unblinding he did not rule out September or if I recall correctly even earlier which makes me think that the SAP is about to be sent to the RAs. I did not get the impression that he believes that the SAP will constitute an unusual challenge to the RAs.
I will be very busy until late tomorrow and if there are any questions, hopefully i will be able to answer tham tomorrow. I am also expecting some vicious attacks.
Recent NWBO News
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 04/21/2026 04:15:08 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
- 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 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
