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Thursday, March 12, 2020 6:07:49 PM
Bruce Patterson :
Quote:
The FDA recommendation for a meeting on CytoDyn’s BTD application is a tremendous opportunity to further discuss the mechanism of action and to summarize the promising results from patients enrolled following the submission of the application. Included in this discussion will be the recent decision by the oncologist of Patient #1 to, based on continued unremarkable changes to her condition, remove carboplatin from the patient’s regimen with continued therapy with leronlimab.
A meeting will give the opportunity to CYDY to incorporate more recent data. Not only the one already submitted but, rather, update FDA of what has been happening ever since.
If Dr. Patterson and Oncologists, Radiologists and MD's make a compelling case we will advance long way towards BTD. Not saying necessarily it will be granted right there but for sure FDA will have lots of info to achieve a speedy decision.
Very positive news in my opinion.
Recent CYDY News
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/13/2024 04:15:06 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/07/2024 12:44:56 AM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 09/07/2024 12:42:22 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/15/2024 09:21:30 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/22/2024 01:00:58 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:17:48 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:16:28 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 12:46:25 PM
- 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 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
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