#CYDY CONVERSATIONS UPDATE#

But I did listen to it again as you suggested :-) some minutes ago on the iHub board. I did not understand the reason for that much noise about this video over the past days. CYDY IS applying for BTD (which I had a question since our 1b/2 MTNBC results) and we all know how much a BTD is worth right? :) It sure helped my expectations.Īdded bonus: A company can't get BTD for any indications, unless they obivously apply for it. Hope the breakdown and links, timelines helped someone. Asking for priority review should be done (according to the above timelines and perhaps earlier) in November, places us in March/Apri 2022 for a PDUFA. IF there are no additional comments come in the next month after submission on Sept 1st, we ARE GOLDEN as it seems the FDA is quickly sending back communications. The next submission is due Sept 1st (Module 2) in 2 weeks and then finally the last one (module 5) on the 15th of October. We have comments currently from the FDA as of a few days ago. We also know that Recknor mentioned in a previous CC that the 'hardest' part of the BLA was done (the Dosage and ROT).

We know we are still Fast Tracked with the BLA submission: CytoDyn plans to submit the requested information and will ask for a Type A meeting with the FDA per the agency’s suggestion

#CYDY CONVERSATIONS UPDATE#

Update on HIV-BLA-PDUFA: FDA requested more information to complete a substantive review. 'CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV PatientsĬytoDyn Clarifies Status of Biologics License ApplicationĬytoDyn Completed Submission of All Remaining Parts of Biologics License Application (“BLA”) on May 11, 2020ĬytoDyn Files Request With FDA for Priority Review of BLA for First ApprovalĬytoDyn Receives BLA Acknowledgment Letter From the FDA This was CYDY's previous submission PR's for HIV:

Cydy conversations