Thursday, October 20, 2022 3:30:07 PM
You may be right, I don't monitor that many companies, the ones I have been involved it don't announce until something's been accepted.
When it comes to new trials, I cannot say how many times an investor stumbling through Clinical Trials found a new trial for a drug in the database, the company never announced filing. In the case of IND's I know the filing is made and presumed to be accepted after a period of days, no FDA document is generated accepting the trial. After the IND's been accepted, the IRB where the lead clinician is operating at actually finalizes the trial protocol, and that can take months after the IND has been accepted. In short, Investors seem to think that things can happen in days that frequently take weeks, months, and sometimes even years.
I hate to say it, but in the case of IMGN, PR's were often released after investors found things in places like clinical trials. Many of us wondered if the company would have even released a PR had investors not found out about the event first. As the company grew, the milestone payments they received from partners didn't even get PR's, they were simply stated in the quarterly statements. I don't know why companies don't highlight good news, but I believe that many others are like IMGN, they reach the point where even $1 million isn't considered big enough to call it a material event. Investors believe that all sorts of things should be considered material events, clearly many companies don't agree.
If a company has a partner paying a substantial milestone payment for say filing a BLA, then it's a material event, but if no money is paid for it occurring, it seems to be up to the company to issue a PR or not. Many companies are like NWBO and issue few such PR's. To my knowledge NWBO has no milestone payments as they have no partner on the hook to make them, the decision to issue a PR is up to them, and regulatory requirements, if any such regulations exist.
Gary
When it comes to new trials, I cannot say how many times an investor stumbling through Clinical Trials found a new trial for a drug in the database, the company never announced filing. In the case of IND's I know the filing is made and presumed to be accepted after a period of days, no FDA document is generated accepting the trial. After the IND's been accepted, the IRB where the lead clinician is operating at actually finalizes the trial protocol, and that can take months after the IND has been accepted. In short, Investors seem to think that things can happen in days that frequently take weeks, months, and sometimes even years.
I hate to say it, but in the case of IMGN, PR's were often released after investors found things in places like clinical trials. Many of us wondered if the company would have even released a PR had investors not found out about the event first. As the company grew, the milestone payments they received from partners didn't even get PR's, they were simply stated in the quarterly statements. I don't know why companies don't highlight good news, but I believe that many others are like IMGN, they reach the point where even $1 million isn't considered big enough to call it a material event. Investors believe that all sorts of things should be considered material events, clearly many companies don't agree.
If a company has a partner paying a substantial milestone payment for say filing a BLA, then it's a material event, but if no money is paid for it occurring, it seems to be up to the company to issue a PR or not. Many companies are like NWBO and issue few such PR's. To my knowledge NWBO has no milestone payments as they have no partner on the hook to make them, the decision to issue a PR is up to them, and regulatory requirements, if any such regulations exist.
Gary
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
