Dear IH CYDY Board,
I am upwithstock on Subreddit LT and Livimmune
I have not posted here before, mainly because for me it has not been a user friendly experience. But occasionally I come here to read mainly ohm20; but I scan thru other posts from time to time and happen to see some posts that don't really seem to know the FDA process but comment on like they do. Plus, they don't seem to understand what has to be in place if you submit a BLA.
Any pharma company that submits a BLA, especially their first one (CYDY?), can be audited before the BLA is fully accepted or right after to see if the company is in FULL compliance with all things FDA. So what does that really mean? There are BOAT LOADS of quality documents that need to be in place for the drug, the CMC, the surveillance of trials and if approved a surveillance program for tracking complaints, adverse events and other possible quality issues. Like sterility, packaging, shipping container issues that could contaminate to product on the inside. All formulary documentation and I am not exaggerating when I say this but there is a ton more quality systems stuff that would blow your mind. Not even the safety data and trial data.
Why is this knowledge important? People don't seem to understand WHY, Cyrus pulled the HIV BLA back. The third party consultants that were hired and they were ex-FDA reviewers basically said if CYDY would submit a BLA, CYDY would not survive the AUDIT the FDA would surely do, because it would have been our first BLA submnission. Those generally get audited to make sure that all of the stuff I mentioned above and all of the other stuff I have not mentioned are in place and up to date. NP may of had 10% of this in place thanks to Nite Ray and the CMC data.
Because the audit team clearly saw nothing else was even close, they recommend to Cyrus to pull the HIV bLa submission. SMART MOVE.
But the third party auditors were not done working on all of the Amarex crap. Long story short, the auditors were able to validate the RAW DATA. This is the data that is cloected by clinicians that interface with the patients collect and eventually put into the electronic files. The CRO does not do that. They takle the electronic data and then basically agregate it and then they are supposed to put it the correct format. They are also supposed to follow strict surveillance protocols and other things. Amarex obviously failed all that. But, the data and the safety was intact. That is why Cyrus changed course and started talking more about HIV and HIV was mentioned more and more in SEC filings which I reference a TON in my posts. IMO and other familiar with BLA filings that the majority of the documents and other documents CYDY was working on are for passing a BLA submission audit. We HAVE NO DOUBTS ABOUT THAT. The clinical hold will be lifted and we feel based on experience that a BLA resubmission will happen at a minimum.
Regarding PIVOTAL TRIALS. geez... just look it up. The FDA and the sponsor in this case CYDY have reported that the HIV - MDR phase 2b/3 trial is a PIVOTAL TRIAL.Its in the 10K!! Meaning that the results would be submitted with the BLA submission and that trials data would be used to vote and yes or no at the PDUFA review. SO everything technically was achieved in the PIVOTAL TRIAL accept the freaking CRO screwed us.
Therefore, with all of the recent discoberies of the shennigans that the FDA pulled with Suzanne Strayhorn and Amarex screwing us. The FDA had the UNUSUAL PDUFA-likje panel meeting. The only thing different about that meeting is: it was not public (PDUFA meetings are public) and there was not vote of yes or no...as far as we know. IMO, the FDA has a credibility issue and also understands that CYDY got screwed from multiple directions. Since there seems to be unprecedent FDA failings and they don't want this to go public. it already has, but they have been help Cyrus with all of the other things CYDY needs to have in place to pass a BLA audit.
This has attributed to the length of time it has taken to get to this point and iMO CYDY had to be silent about a lot of this shit.
My apologies for Capital letters but I have been misquoted too many times. I wish all the longs the very best. Most importantly I hope and pray that CYDY can move forward and get LL into physicians hands to start treating patients in need. I thank you all for your patience with this long post.
Happy Thanksgiving from MLAB/Upwithstock
I am upwithstock on Subreddit LT and Livimmune
I have not posted here before, mainly because for me it has not been a user friendly experience. But occasionally I come here to read mainly ohm20; but I scan thru other posts from time to time and happen to see some posts that don't really seem to know the FDA process but comment on like they do. Plus, they don't seem to understand what has to be in place if you submit a BLA.
Any pharma company that submits a BLA, especially their first one (CYDY?), can be audited before the BLA is fully accepted or right after to see if the company is in FULL compliance with all things FDA. So what does that really mean? There are BOAT LOADS of quality documents that need to be in place for the drug, the CMC, the surveillance of trials and if approved a surveillance program for tracking complaints, adverse events and other possible quality issues. Like sterility, packaging, shipping container issues that could contaminate to product on the inside. All formulary documentation and I am not exaggerating when I say this but there is a ton more quality systems stuff that would blow your mind. Not even the safety data and trial data.
Why is this knowledge important? People don't seem to understand WHY, Cyrus pulled the HIV BLA back. The third party consultants that were hired and they were ex-FDA reviewers basically said if CYDY would submit a BLA, CYDY would not survive the AUDIT the FDA would surely do, because it would have been our first BLA submnission. Those generally get audited to make sure that all of the stuff I mentioned above and all of the other stuff I have not mentioned are in place and up to date. NP may of had 10% of this in place thanks to Nite Ray and the CMC data.
Because the audit team clearly saw nothing else was even close, they recommend to Cyrus to pull the HIV bLa submission. SMART MOVE.
But the third party auditors were not done working on all of the Amarex crap. Long story short, the auditors were able to validate the RAW DATA. This is the data that is cloected by clinicians that interface with the patients collect and eventually put into the electronic files. The CRO does not do that. They takle the electronic data and then basically agregate it and then they are supposed to put it the correct format. They are also supposed to follow strict surveillance protocols and other things. Amarex obviously failed all that. But, the data and the safety was intact. That is why Cyrus changed course and started talking more about HIV and HIV was mentioned more and more in SEC filings which I reference a TON in my posts. IMO and other familiar with BLA filings that the majority of the documents and other documents CYDY was working on are for passing a BLA submission audit. We HAVE NO DOUBTS ABOUT THAT. The clinical hold will be lifted and we feel based on experience that a BLA resubmission will happen at a minimum.
Regarding PIVOTAL TRIALS. geez... just look it up. The FDA and the sponsor in this case CYDY have reported that the HIV - MDR phase 2b/3 trial is a PIVOTAL TRIAL.Its in the 10K!! Meaning that the results would be submitted with the BLA submission and that trials data would be used to vote and yes or no at the PDUFA review. SO everything technically was achieved in the PIVOTAL TRIAL accept the freaking CRO screwed us.
Therefore, with all of the recent discoberies of the shennigans that the FDA pulled with Suzanne Strayhorn and Amarex screwing us. The FDA had the UNUSUAL PDUFA-likje panel meeting. The only thing different about that meeting is: it was not public (PDUFA meetings are public) and there was not vote of yes or no...as far as we know. IMO, the FDA has a credibility issue and also understands that CYDY got screwed from multiple directions. Since there seems to be unprecedent FDA failings and they don't want this to go public. it already has, but they have been help Cyrus with all of the other things CYDY needs to have in place to pass a BLA audit.
This has attributed to the length of time it has taken to get to this point and iMO CYDY had to be silent about a lot of this shit.
My apologies for Capital letters but I have been misquoted too many times. I wish all the longs the very best. Most importantly I hope and pray that CYDY can move forward and get LL into physicians hands to start treating patients in need. I thank you all for your patience with this long post.
Happy Thanksgiving from MLAB/Upwithstock
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