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Posted On: 09/07/2020 11:59:41 AM
Post# of 148893
First time poster so please be kind.
I, like many here have been trying to read the tea leaves as to what tomorrow’s teleconference with the FDA signifies. Blafarm has suggested that this is another stalling tactic by the FDA, and that seems perfectly plausible. Indeed much of our previous dealings with the FDA regarding HIV can easily be read that way.
I’d like to advance another, more optimistic scenario. Perhaps delaying the HIV BLA has been the i the intention all along but things changed. It’s been pointed on here that the MHRA and FDA have an existing cooperation agreement and, as such must have a channel for routine, private communication. Now let’s say the MHRA informed the FDA that based on the data they have a lot of interest in Leronlimab for Covid. This might in fact give the FDA the push to give the drug an EUA quickly.
Now, stay with me here...the FDA has deservedly gotten a lot of flack for their handling of HCQ, Remdesivir, and the fiasco of a press conference for blood plasma. Currently many in this country are worried that because of political pressure, the FDA will approve a vaccine prematurely. The FDA has to be gun shy about the backlash and scrutiny they will receive if they Issue an EUA for Leronlimab for Covid. Only a phase 2 trial, relatively small patient population, small company with no approved drugs, etc.
Accepting our BLA for HIV would be a way of telling the scientific community and media that they have been analyzing trial data for years and they find it a safe and effective drug for HIV, and is, in fact already in last steps for approval for that indication. This would go a long way in providing a tremendous amount of cover from scrutiny for a Covid EUA.
The FDA waited until the last (60th) day to send Cytodyn a RTF... but remember, things have now changed. They responded with written questions early and have agreed to a teleconference (that was previously not considered) very quickly. Additionally on the last conference call Nader alluded that the FDA was not requiring to do much with the 700 mg dose data. I could be remembering wrong but the gist of what I understood was just send us what you already have and we will take care of the rest. It certainly Can be construed that the FDA is now doing everything possible to approve our BLA ASAP. I think they want to issue it either commensurate with or as short a time as possible after a Covid EUA.
I know it’s been posted on here that a review that a BLA resubmission requires a 30+ day review but after some research, that’s not what I’ve found. The manual of policies and procedures for the Center for Drug Evaluation and Research states that if the resubmission is a complete response they will send the applicant an acknowledgment letter within 30 days: Insert-ta https://www.fda.gov/media/72727/download g-here
I have no knowledge of how the FDA works and could be looking at an outdated document so please excuse my ignorance if that’s the case.
On a separate but related note Dr Patterson tweeted recently that his paper is “very close” to being published. The importance of having this done quickly now cannot be overstated. What better cover for the FDA to allay potential concerns of an approval then a peer reviewed paper from a prestigious medical journal that scientifically validates Leronlimab’s MOA against Covid’s disease pathogenis.
I, like many here have been trying to read the tea leaves as to what tomorrow’s teleconference with the FDA signifies. Blafarm has suggested that this is another stalling tactic by the FDA, and that seems perfectly plausible. Indeed much of our previous dealings with the FDA regarding HIV can easily be read that way.
I’d like to advance another, more optimistic scenario. Perhaps delaying the HIV BLA has been the i the intention all along but things changed. It’s been pointed on here that the MHRA and FDA have an existing cooperation agreement and, as such must have a channel for routine, private communication. Now let’s say the MHRA informed the FDA that based on the data they have a lot of interest in Leronlimab for Covid. This might in fact give the FDA the push to give the drug an EUA quickly.
Now, stay with me here...the FDA has deservedly gotten a lot of flack for their handling of HCQ, Remdesivir, and the fiasco of a press conference for blood plasma. Currently many in this country are worried that because of political pressure, the FDA will approve a vaccine prematurely. The FDA has to be gun shy about the backlash and scrutiny they will receive if they Issue an EUA for Leronlimab for Covid. Only a phase 2 trial, relatively small patient population, small company with no approved drugs, etc.
Accepting our BLA for HIV would be a way of telling the scientific community and media that they have been analyzing trial data for years and they find it a safe and effective drug for HIV, and is, in fact already in last steps for approval for that indication. This would go a long way in providing a tremendous amount of cover from scrutiny for a Covid EUA.
The FDA waited until the last (60th) day to send Cytodyn a RTF... but remember, things have now changed. They responded with written questions early and have agreed to a teleconference (that was previously not considered) very quickly. Additionally on the last conference call Nader alluded that the FDA was not requiring to do much with the 700 mg dose data. I could be remembering wrong but the gist of what I understood was just send us what you already have and we will take care of the rest. It certainly Can be construed that the FDA is now doing everything possible to approve our BLA ASAP. I think they want to issue it either commensurate with or as short a time as possible after a Covid EUA.
I know it’s been posted on here that a review that a BLA resubmission requires a 30+ day review but after some research, that’s not what I’ve found. The manual of policies and procedures for the Center for Drug Evaluation and Research states that if the resubmission is a complete response they will send the applicant an acknowledgment letter within 30 days: Insert-ta https://www.fda.gov/media/72727/download g-here
I have no knowledge of how the FDA works and could be looking at an outdated document so please excuse my ignorance if that’s the case.
On a separate but related note Dr Patterson tweeted recently that his paper is “very close” to being published. The importance of having this done quickly now cannot be overstated. What better cover for the FDA to allay potential concerns of an approval then a peer reviewed paper from a prestigious medical journal that scientifically validates Leronlimab’s MOA against Covid’s disease pathogenis.
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