I am not sure this has been posted but very interesting from another Board.
Pivotal drug trials and Dr. Jay Lalezari
Dear Longs,
I have been planning to discuss the meaning of pivotal trials in the drug approval process and then we got very positive news about Dr. Jay Lalezari's appointment as Interim CEO. I will try to tie these together at the end.
First what does it mean that CYDY in the last 10-K filed with the SEC on 9-14-23. Page 6 states:
In 2016, we initiated a pivotal Phase 2b/3 trial for leronlimab as a combination therapy with existing HAART drug regimens for highly treatment-experienced HIV patients. The trial was completed in February 2018 and achieved its primary endpoint with a p-value of 0.0032.
Pivotal trials are the final trial that gets submitted to the FDA for approval. CYDY does not get to make that determination on their own. from u/PharmaJunkee : The FDA and CYDY essentially get together and look at prior data and the design of the proposed 2b/3 trial and then determine whether or not the proposed 2b/3 trial meets the criteria for a "pivotal trial" or not. Once the trial ends and hits the p value (it did .032), and the power of the study meets stat sig. The data is cleaned and formatted correctly then the FDA will recommend a BLA or NDA is filed. It is more of a FDA decision at this point, because the company is already committed.
Obviously we know the story that happened with NP/KK. But, since that time Cyrus has come in and re-evaluated everything and to make a long story short; he put HIV back in play and all kinds of third party audits determined that the data is fine and all of the stat sig criteria was met and WHY NOT resubmit the HIV-BLA. We DID THE TRIAL ALREADY FOR GOD's sake. It was declared a pivotal trial and LL hit the mark. It was the CRO that screwed everything else up, but not the inegroty of the data (Cyrus said those very words).
Then as I have mentioned in the past Cyrus had a unusual panel- like, advisory committee - like meeting with the FDA. It included KOLs in the HIV space and Dr. Jay Lalezari is a prominent KOL in the HIV space. CYDY had other KOLs fly in from all over, along with patient advocates to have presentations and open discussions with the FDA about LL and HIV. Antonio told us how excited everyone seemed to be and that it was a lot of effort to schedule the wide variety of folks to attend this FDA meeting. LET ME SAY: this sounded very similar to ADCOM meetings and or PDUFA meetings.
I have long suspected prior to the panel-like meeting that CYDY the clinical hold documents and BLA documents have a lot of crossover and duplication. NO doubt that there are parallel submissions going on which I believe have extended the time for this whole clinical hold to be released. I also, believe that Dr. Jay has been instrumental is these meetings with the FDA to release the hold and resubmit the BLA.
Dr. Jay is apparently not taking a lot of compensation for his interim role. He has always given me the impression that he enjoys a certain independence with his projects and wants to maintain that as much as possible. Some Research scientists want to rule out bias as much as possible and he has that pure DNA in his blood. He knows how good LL is and he is trying to help CYDY cross the finish line.
To conclude, Dr. Jay Lalezari's role as interim is just that, temporary and he will hand the keys over to whoever is buying CYDY and or the new seasoned Pharma exec that will guide CYDY thru the partnering process. Furthermore, I have said this before, the panel-like/ advisory committee-like FDA meetings that CYDY had with the FDA reviewed all of the cleaned up/reformatted/audited data, and the FDA determined it was good enough for a FDA APPROVAL. After all, those prior meetings were handled just like a PDUFA review. The HIV trial protocol request from the FDA is a POST APPROVAL TRIAL. this post approval trial is sometimes known as a phase four, but it is used by the FDA to study the drug further after approval. THIS IS NOT anEUA. I have referenced the link for post approval trials in the past on the FDA web-site.
This is truly a remarkable moment and the turn around has been in play for awhile and it is starting to bloom. Happy Thanksgiving and THANK YOU GOD, THANK YOU UNIVERSE, for this wonderful GIFT.
Pivotal drug trials and Dr. Jay Lalezari
Dear Longs,
I have been planning to discuss the meaning of pivotal trials in the drug approval process and then we got very positive news about Dr. Jay Lalezari's appointment as Interim CEO. I will try to tie these together at the end.
First what does it mean that CYDY in the last 10-K filed with the SEC on 9-14-23. Page 6 states:
In 2016, we initiated a pivotal Phase 2b/3 trial for leronlimab as a combination therapy with existing HAART drug regimens for highly treatment-experienced HIV patients. The trial was completed in February 2018 and achieved its primary endpoint with a p-value of 0.0032.
Pivotal trials are the final trial that gets submitted to the FDA for approval. CYDY does not get to make that determination on their own. from u/PharmaJunkee : The FDA and CYDY essentially get together and look at prior data and the design of the proposed 2b/3 trial and then determine whether or not the proposed 2b/3 trial meets the criteria for a "pivotal trial" or not. Once the trial ends and hits the p value (it did .032), and the power of the study meets stat sig. The data is cleaned and formatted correctly then the FDA will recommend a BLA or NDA is filed. It is more of a FDA decision at this point, because the company is already committed.
Obviously we know the story that happened with NP/KK. But, since that time Cyrus has come in and re-evaluated everything and to make a long story short; he put HIV back in play and all kinds of third party audits determined that the data is fine and all of the stat sig criteria was met and WHY NOT resubmit the HIV-BLA. We DID THE TRIAL ALREADY FOR GOD's sake. It was declared a pivotal trial and LL hit the mark. It was the CRO that screwed everything else up, but not the inegroty of the data (Cyrus said those very words).
Then as I have mentioned in the past Cyrus had a unusual panel- like, advisory committee - like meeting with the FDA. It included KOLs in the HIV space and Dr. Jay Lalezari is a prominent KOL in the HIV space. CYDY had other KOLs fly in from all over, along with patient advocates to have presentations and open discussions with the FDA about LL and HIV. Antonio told us how excited everyone seemed to be and that it was a lot of effort to schedule the wide variety of folks to attend this FDA meeting. LET ME SAY: this sounded very similar to ADCOM meetings and or PDUFA meetings.
I have long suspected prior to the panel-like meeting that CYDY the clinical hold documents and BLA documents have a lot of crossover and duplication. NO doubt that there are parallel submissions going on which I believe have extended the time for this whole clinical hold to be released. I also, believe that Dr. Jay has been instrumental is these meetings with the FDA to release the hold and resubmit the BLA.
Dr. Jay is apparently not taking a lot of compensation for his interim role. He has always given me the impression that he enjoys a certain independence with his projects and wants to maintain that as much as possible. Some Research scientists want to rule out bias as much as possible and he has that pure DNA in his blood. He knows how good LL is and he is trying to help CYDY cross the finish line.
To conclude, Dr. Jay Lalezari's role as interim is just that, temporary and he will hand the keys over to whoever is buying CYDY and or the new seasoned Pharma exec that will guide CYDY thru the partnering process. Furthermore, I have said this before, the panel-like/ advisory committee-like FDA meetings that CYDY had with the FDA reviewed all of the cleaned up/reformatted/audited data, and the FDA determined it was good enough for a FDA APPROVAL. After all, those prior meetings were handled just like a PDUFA review. The HIV trial protocol request from the FDA is a POST APPROVAL TRIAL. this post approval trial is sometimes known as a phase four, but it is used by the FDA to study the drug further after approval. THIS IS NOT anEUA. I have referenced the link for post approval trials in the past on the FDA web-site.
This is truly a remarkable moment and the turn around has been in play for awhile and it is starting to bloom. Happy Thanksgiving and THANK YOU GOD, THANK YOU UNIVERSE, for this wonderful GIFT.
8
