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Monday, August 21, 2017 8:43:50 AM
The bad news is the 10/17 FDA meeting is sufficiently far away to complicate the chance of raising money to keep the company going. I have to assume they will find a way to financially get to 10/17 somehow as the stakes are just too high not to do so. But the company may not be meeting payroll in September.
The weird aspect of this is the apparent fact that either the trial was allowed to proceed without a well-defined protocol or the company is trying to change the agreed upon protocol with regard to analyzing the primary endpoint. It would have been appropriate for the company to explain this need for an FDA meeting before being able to produce the analysis of the primary endpoint. You will note the time frame for that meeting went from "coming weeks" to 10/17. I suspect we all hoped it would have been in late August or early September when we heard the "coming weeks" description. It does not seem like the FDA is in a rush to get this meeting on the agenda, but they are always moving slower than investors prefer.
Also, if a PR is not unambiguously good news, it likely hiding some bad news. Can some of the CYDY bulls offer up a good explanation for the need to meet with the FDA rather than just report out the results. With almost all patients completing the trial so far staying on PRO 140, what could possibly be the reason for not just analyzing and publishing the primary endpoint results? Then again, maybe they will do that and the meeting with the FDA is about other aspects of the data analysis, but you would think they would tell us that if it was the plan.
Recent CYDY News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
- Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:15:34 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/22/2024 05:15:08 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 10:31:57 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/29/2024 10:22:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/29/2024 01:40:14 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/19/2024 10:15:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 01/16/2024 10:16:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:57 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:20 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:02:59 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:02:30 AM
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