Friday, March 22, 2019 10:51:11 AM
I know you said "nevermind" regarding your initial question, but for the sake of others that may have the same question or even be wondering what your question meant...
There is currently no PDUFA date for leronlimab. A PDUFA (which stands for Prescription Drug User Fee Act) date is a date that the FDA commits to providing some level of response to an NDA or BLA prior to, and is generated based on the date of acceptance of the NDA/BLA filing and any special statuses of the drug. For example, BTD/ODD/Fast Track may shorten the PDUFA time frame from ~10 months to ~6 months post-acceptance. Acceptance means only that the FDA feels that the filing is sufficiently complete to allow for review... and that's when the clock starts on the PDUFA date. Acceptance (or rejection) of a filing typically happens within about 60 days of receipt of a complete filing.
For CYDY, the FDA will not make a determination on acceptance of the BLA prior to having the entire BLA, thus the company does not yet have a PDUFA date. What the Rolling Review allows for is potential shortening of time frames once the entire BLA is in. For example, even though the FDA has ~60 days to review and accept/reject a BLA, it doesn't have to take all of that time. They may be able to accept within 30 days, hypothetically, if they've had a chance to review major portions of the submission prior to receiving the complete submission. Thus, the PDUFA date could be maybe a month earlier than might be expected given only the date of the final submission of the BLA under normal circumstances. Similarly, the PDUFA date is a deadline to approve, reject, ask for more information, or issue a Complete Response Letter (i.e. you're not approved... but you probably can get there if you fix certain things). There is nothing that precludes the FDA from acting prior to the PDUFA date, and indeed they have recently approved drugs months ahead of the PDUFA date. This is one of the major benefits of the FDA agreeing to actually review the submission on a rolling basis - time frames to approval could potentially be shortened by up to several months.
Again, not intended as an education for you, RockerV. Simply clearing up the question for others who may be following along at home.
Recent CYDY News
- 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
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:01:55 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:01:14 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 10:15:19 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM