Dear Longs, I hope everyone had a great Thanksgiving! I would like to apologize for the first post on this site as being rife with mistakes on grammar, misspellings, missed words, wrong words....it was not an easy read and yet you all understood what I was trying to say. Thank you all for your kindness.
I wanted to clarify a couple of questions that ohm20 had:
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The CRO or pharma company (if directly running the trial) are responsible for validating data. Do you think the FDA accepts un-validated data. Validating tens or hundreds of thousands of points of data across over six hundred patients would have astronomical costs and a very long timeline. Almost certainly the companies hired to review feasibility looked to see if the data existed at the clinics and what the cost of recovery, validation and BLA submittal would be.
Myy Comments:
CRO's or pharma companies (if running a trial directly) are not allowed to interface with the patients at all, in any way, shape or form. The hospitals/Clinics/Clinicians & staff are the only ones to interface with the patients (especially patients in the trial). These folks collect the raw data and put it into the patient charts/PHI/electronic files.
The CRO's have access to those electronic files to aggregate/compute and analyze the data. If that data is screwed with in anyway, that is a MAJOR VIOLATION. I do not believe that any of us investors know if the Amarex folks went that far? But, with all of the other discoveries of wrong doing by Amarex; I know my companies would have requested and paid the 3rd party auditors to insure that the data is truly intact and is not tainted in anyway. These are the precautions, and costs that I believe CYDY had to take to insure everything is in compliance, and the integrity of the data is up to standards. Yes, it takes a long time and yes it was necessary.
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I'm not sure which meeting you are talking about. If it's a meeting about the BLA submission between the FDA and the Sponsor they're not public. If it's internal FDA meetings to review the final decision on a BLA submission they're not public either. If it's a meeting about the safety hold being lifted or a possible BLA resubmission those are an FDA/Sponor meeting and are also not public.
My comments:
CYDY has announced in their SEC filings and during the 7-24-23 CC, that CYDY and the FDA have had several informal meetings. CYDY referred to one of those informal meetings: it was a meeting that the FDA, had CYDY invited Key Physician Opinion Leaders from the HIV space, and Patient Advocates. Antonio even commented how challenging this meeting was to coordinate all these experts to attend. Must have been a known date in the future to be able to plan and coordinate all those folks. I laughed when I heard that, because generally speaking you have all of those experts show up for a ADCOM of PDUFA review meeting, which takes the same type of planning and coordination.
I have referred to those meetings as "panel meetings", because not only does the trial sponsor have a slew of experts and sometimes patients attending those meetings, but the FDA has a panel of well qualified experts there on their own. Of course we were not given the full extend of those details. Therefore, I am left to speculate a bit on this UNUSUAL meeting. First, I have never heard of this type of expert gathering come together for a "clinical Hold" meeting. Second, the description we got from CYDY, was very very similar to a Panel meeting (ADCOM or PDUFA). Why have all those experts there for just a Clinical hold meeting or what you are suggesting just a BLA submission. If it was a just for a BLA submission meeting, the way it was presented to us would again be unusual. However, you need to submit the BLA, before you get approval, so I don't doubt that the BLA was discussed...maybe even a formal submission was made. After all you stated that a BLA submission meeting is not public.
Bottomline, for me and I believe you as well, that there are larger submissions at play between CYDY and the FDA, then just a clinical hold update/submission.
We all should know at this point that HIV is back in play, because the result of that UNUSUAL meeting was that CYDY was supposed to submit a "clinical protocol" for one of five HIV sub-populations.
Yes, those were the exact words that we first got from CYDY: "Clinical protocol". Later on we finally received a little clarity and it was stated as: "Trial Protocol". None of us really know what that trial protocol really is. Nonetheless, I have stated in a previous posts here and on other boards; that it is entirely possible for it to be a POST APPROVAL TRAIL. This is in the FDA armamentarium that they can use with a trial sponsor. A post approval trial is often agreed upon before the FDA issues their final approval decision.
There are a lot of us with experience that have a high degree of confidence that the amount of time, consultant resources, and the number of informal meetings (CYDY says that had "several" informal meetings); that there is a lot more going on than the just the clinical hold. IMO, in the almost two years that we have been waiting; a lot could more could have and may have been accomplished.
What I am expecting:
1) Lifting of the clinical hold
2) BLA submission and the BLA is accepted (technically it's 60 day process + 14 days for setting a PDUFA date)
3) This is a stretch I know, but I believe we had the PDUFA panel meeting. And the FDA reviewed the PIVOTAL PH 2b/3 trial data for HIV-MDR. Whats wrong with this thesis: A) Those meetings are PUBLIC (this was not)
Why would FDA then give CYDY a choice of 5 sub-populations if we are getting FDA approval on HIV-MDR? (I have no rationale answer, unless they gave approval to HIV-MDR, and said to CYDY do a trail protocol on one other HIV indication of five) IDK..
4) With the news of Dr. Lalezari as Interim CEO, IMO, he was one of the Key Opinion Leaders attending that UNUSUAL informal meeting
As I have always said, except for my first post on IH. I" am not an insider, nor do I possess any insider information. This is my thesis, and my opinion.
I wish everyone a great weekend. God Bless to All
I wanted to clarify a couple of questions that ohm20 had:
____________________________________________________________
The CRO or pharma company (if directly running the trial) are responsible for validating data. Do you think the FDA accepts un-validated data. Validating tens or hundreds of thousands of points of data across over six hundred patients would have astronomical costs and a very long timeline. Almost certainly the companies hired to review feasibility looked to see if the data existed at the clinics and what the cost of recovery, validation and BLA submittal would be.
Myy Comments:
CRO's or pharma companies (if running a trial directly) are not allowed to interface with the patients at all, in any way, shape or form. The hospitals/Clinics/Clinicians & staff are the only ones to interface with the patients (especially patients in the trial). These folks collect the raw data and put it into the patient charts/PHI/electronic files.
The CRO's have access to those electronic files to aggregate/compute and analyze the data. If that data is screwed with in anyway, that is a MAJOR VIOLATION. I do not believe that any of us investors know if the Amarex folks went that far? But, with all of the other discoveries of wrong doing by Amarex; I know my companies would have requested and paid the 3rd party auditors to insure that the data is truly intact and is not tainted in anyway. These are the precautions, and costs that I believe CYDY had to take to insure everything is in compliance, and the integrity of the data is up to standards. Yes, it takes a long time and yes it was necessary.
________________________________________________________________
I'm not sure which meeting you are talking about. If it's a meeting about the BLA submission between the FDA and the Sponsor they're not public. If it's internal FDA meetings to review the final decision on a BLA submission they're not public either. If it's a meeting about the safety hold being lifted or a possible BLA resubmission those are an FDA/Sponor meeting and are also not public.
My comments:
CYDY has announced in their SEC filings and during the 7-24-23 CC, that CYDY and the FDA have had several informal meetings. CYDY referred to one of those informal meetings: it was a meeting that the FDA, had CYDY invited Key Physician Opinion Leaders from the HIV space, and Patient Advocates. Antonio even commented how challenging this meeting was to coordinate all these experts to attend. Must have been a known date in the future to be able to plan and coordinate all those folks. I laughed when I heard that, because generally speaking you have all of those experts show up for a ADCOM of PDUFA review meeting, which takes the same type of planning and coordination.
I have referred to those meetings as "panel meetings", because not only does the trial sponsor have a slew of experts and sometimes patients attending those meetings, but the FDA has a panel of well qualified experts there on their own. Of course we were not given the full extend of those details. Therefore, I am left to speculate a bit on this UNUSUAL meeting. First, I have never heard of this type of expert gathering come together for a "clinical Hold" meeting. Second, the description we got from CYDY, was very very similar to a Panel meeting (ADCOM or PDUFA). Why have all those experts there for just a Clinical hold meeting or what you are suggesting just a BLA submission. If it was a just for a BLA submission meeting, the way it was presented to us would again be unusual. However, you need to submit the BLA, before you get approval, so I don't doubt that the BLA was discussed...maybe even a formal submission was made. After all you stated that a BLA submission meeting is not public.
Bottomline, for me and I believe you as well, that there are larger submissions at play between CYDY and the FDA, then just a clinical hold update/submission.
We all should know at this point that HIV is back in play, because the result of that UNUSUAL meeting was that CYDY was supposed to submit a "clinical protocol" for one of five HIV sub-populations.
Yes, those were the exact words that we first got from CYDY: "Clinical protocol". Later on we finally received a little clarity and it was stated as: "Trial Protocol". None of us really know what that trial protocol really is. Nonetheless, I have stated in a previous posts here and on other boards; that it is entirely possible for it to be a POST APPROVAL TRAIL. This is in the FDA armamentarium that they can use with a trial sponsor. A post approval trial is often agreed upon before the FDA issues their final approval decision.
There are a lot of us with experience that have a high degree of confidence that the amount of time, consultant resources, and the number of informal meetings (CYDY says that had "several" informal meetings); that there is a lot more going on than the just the clinical hold. IMO, in the almost two years that we have been waiting; a lot could more could have and may have been accomplished.
What I am expecting:
1) Lifting of the clinical hold
2) BLA submission and the BLA is accepted (technically it's 60 day process + 14 days for setting a PDUFA date)
3) This is a stretch I know, but I believe we had the PDUFA panel meeting. And the FDA reviewed the PIVOTAL PH 2b/3 trial data for HIV-MDR. Whats wrong with this thesis: A) Those meetings are PUBLIC (this was not)
Why would FDA then give CYDY a choice of 5 sub-populations if we are getting FDA approval on HIV-MDR? (I have no rationale answer, unless they gave approval to HIV-MDR, and said to CYDY do a trail protocol on one other HIV indication of five) IDK.. 4) With the news of Dr. Lalezari as Interim CEO, IMO, he was one of the Key Opinion Leaders attending that UNUSUAL informal meeting
As I have always said, except for my first post on IH. I" am not an insider, nor do I possess any insider information. This is my thesis, and my opinion.
I wish everyone a great weekend. God Bless to All
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