Ok, here is my theory.
Seethamraju will be very mad if leronlimab is effective for patients and the FDA doesn't provide patients with access.
On the last go-round with Seethamraju, back around March 7, the FDA capitulated to Sethamraju's demand that he be permitted to treat is severely ill patients with leronlimab despite the fact that there was zero data for LL in covid, there were no preclinical studies, and the FDA scientists saw no theoretical reason why Ll would do even the slightest thing.
So what will Seethamraju do on this next go-round, AFTER LL HAS BEEN PROVEN TO WORK, no matter if its 25% or 50% mortality reduction, and the FDA does not allow Seethamraju to treat his severely ill patients with something that he knows, for certain, might save their lives?
Maybe I am misreading Seethamraju. Maybe he is just a mild mannered, soft spoken guy who has coincidentally made some odd comments.
Maybe its just happenstance that Seethamraju happened to find out that the FDA was reviewing CD12 data.
Maybe Seethamraju didn't know that he shouldn't be speaking about FDA deliberations that were supposed to be kept secret.
Maybe the FDA plans to insert themselves into every covid interim analysis, and this time the FDA just forgot to let everyone know that they were reviewing CD12.
Maybe Seethamraju is a loudmouthed loose cannon, just exactly the sort of person to blurt out secret FDA deliberations unexpectedly, while his colleague, Nader Pourhassan, master of the sublime, holds his cards close to his chest.
The FDA has CYDY on a short leash.
Seems the same cannot be said about Seethamraju.
If Seethamraju is really not the soft spoken, mild mannered guy he appears to be in the Oct 7 video, then the folks at the FDA may be concerned that he might speak up and make them look bad.
Why does Seethamraju know what the FDA is doing on CD12?
Why is Seethamraju the only person to describe the FDA's activities on CD12?
If I am a CD12 reviewer at the FDA, and I am afraid of Seethamraju, I think I would check in with him.
Maybe I would tell Seethamraju that the FDA is very interested in LL, and then I would even tell him that I was looking at the CD12 data. Maybe I would tell him to keep quiet about that, maybe not.
Entirely possible Seethamraju learned of the FDA's work accidentally and went on to blurt it out unexpectedly.
What would Seethamraju extract from the FDA?
Indeed a very good question.
What bone can the FDA throw to CYDY to keep Seethamraju happy in the event that the interim analysis shows that Seethamraju should be treating his patients with LL?
The only bone I can see that the FDA can throw is some sort of squishy, optimistic language that CYDY would be encouraged to use, and that the purpose of this squishy, optimistic language is to speed up enrollment in CD12 and get it wrapped up quickly. If CD12 interim results are good but not fully dispositive, then Seethaamraju can be appeased with the notion that the CD12 trial will speed up and conclude quickly.
Patterson's tweets are at least mildly indirect and he often defers questions to CYDY. Patterson clearly feels constrained in speaking on some topics.
As far as we know, Seethamraju has spoken on LL only twice. The first time was to get the EINDs. The second time he revealed that the FDA was working on CD12 interim analysis. Methinks the guy who is revealing secret FDA deliberations is not on anyone's leash
Seethamraju will be very mad if leronlimab is effective for patients and the FDA doesn't provide patients with access.
On the last go-round with Seethamraju, back around March 7, the FDA capitulated to Sethamraju's demand that he be permitted to treat is severely ill patients with leronlimab despite the fact that there was zero data for LL in covid, there were no preclinical studies, and the FDA scientists saw no theoretical reason why Ll would do even the slightest thing.
So what will Seethamraju do on this next go-round, AFTER LL HAS BEEN PROVEN TO WORK, no matter if its 25% or 50% mortality reduction, and the FDA does not allow Seethamraju to treat his severely ill patients with something that he knows, for certain, might save their lives?
Maybe I am misreading Seethamraju. Maybe he is just a mild mannered, soft spoken guy who has coincidentally made some odd comments.
Maybe its just happenstance that Seethamraju happened to find out that the FDA was reviewing CD12 data.
Maybe Seethamraju didn't know that he shouldn't be speaking about FDA deliberations that were supposed to be kept secret.
Maybe the FDA plans to insert themselves into every covid interim analysis, and this time the FDA just forgot to let everyone know that they were reviewing CD12.
Maybe Seethamraju is a loudmouthed loose cannon, just exactly the sort of person to blurt out secret FDA deliberations unexpectedly, while his colleague, Nader Pourhassan, master of the sublime, holds his cards close to his chest.
The FDA has CYDY on a short leash.
Seems the same cannot be said about Seethamraju.
If Seethamraju is really not the soft spoken, mild mannered guy he appears to be in the Oct 7 video, then the folks at the FDA may be concerned that he might speak up and make them look bad.
Why does Seethamraju know what the FDA is doing on CD12?
Why is Seethamraju the only person to describe the FDA's activities on CD12?
If I am a CD12 reviewer at the FDA, and I am afraid of Seethamraju, I think I would check in with him.
Maybe I would tell Seethamraju that the FDA is very interested in LL, and then I would even tell him that I was looking at the CD12 data. Maybe I would tell him to keep quiet about that, maybe not.
Entirely possible Seethamraju learned of the FDA's work accidentally and went on to blurt it out unexpectedly.
What would Seethamraju extract from the FDA?
Indeed a very good question.
What bone can the FDA throw to CYDY to keep Seethamraju happy in the event that the interim analysis shows that Seethamraju should be treating his patients with LL?
The only bone I can see that the FDA can throw is some sort of squishy, optimistic language that CYDY would be encouraged to use, and that the purpose of this squishy, optimistic language is to speed up enrollment in CD12 and get it wrapped up quickly. If CD12 interim results are good but not fully dispositive, then Seethaamraju can be appeased with the notion that the CD12 trial will speed up and conclude quickly.
Patterson's tweets are at least mildly indirect and he often defers questions to CYDY. Patterson clearly feels constrained in speaking on some topics.
As far as we know, Seethamraju has spoken on LL only twice. The first time was to get the EINDs. The second time he revealed that the FDA was working on CD12 interim analysis. Methinks the guy who is revealing secret FDA deliberations is not on anyone's leash
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