Cytodyn Inc (CYDY)

[BlackDoggie]

Agreed, welcome RockerV.

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.