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Posted On: 08/12/2020 10:15:07 AM
Post# of 148870
Just tying-off some loose ends:
Last night Dr.BP disclosed that a viral load assay was indeed not run for the M/M trial because it wasn't in the protocol. He did say that it could be run now, but it requires a 0.5 ml sample. He indicated that IncellDx had meticulously stored all of the samples from the trials, and I got the impression it could be run, but someone was going to have to pay for it.
It's easy to understand why viral load was not included, not only is this a M/M cohort that might not show a dramatic increase or decrease in viral load, but the M/M protocol was very possibly drafted before the notion of viral load was brought to the forefront.
And since viral load isn't in the S/C protocol either, it looks like we won't be able to tell that part of the story to the FDA. Actually, in spite of Dr.NP saying that Dr.BP was running labs for both the M/M and S/C trials, the S/C protocol does not include the any of the Dr.BP assays that can be found in the M/M protocol. I find this to be a bit troubling because the endpoints seem quite binary and uninformative in terms of shedding light on the MOA.
S/C Protocol Link: https://clinicaltrials.gov/ct2/show/NCT04347239
Dr.BP also described the FDA as being a statistical analysis-based organization and that they don't have the time or inclination to research papers on drugs they are reviewing. He was very clearly discounting the value of his peer reviewed paper in terms of influencing the FDA's approval process in our favor. So, again, this important part of the story will not be exposed to the FDA, or the media (unless the media digs-in to find it -- which will rarely occur in our attention deficit, soundbite world).
I suppose future COVID trials (PrEP, Long Haul, Competitive 3-Arm) might include this level of granularity, but I admit to being disappointed that we don't have the opportunity to tell this part of the amazing story right now.
Last night Dr.BP disclosed that a viral load assay was indeed not run for the M/M trial because it wasn't in the protocol. He did say that it could be run now, but it requires a 0.5 ml sample. He indicated that IncellDx had meticulously stored all of the samples from the trials, and I got the impression it could be run, but someone was going to have to pay for it.
It's easy to understand why viral load was not included, not only is this a M/M cohort that might not show a dramatic increase or decrease in viral load, but the M/M protocol was very possibly drafted before the notion of viral load was brought to the forefront.
And since viral load isn't in the S/C protocol either, it looks like we won't be able to tell that part of the story to the FDA. Actually, in spite of Dr.NP saying that Dr.BP was running labs for both the M/M and S/C trials, the S/C protocol does not include the any of the Dr.BP assays that can be found in the M/M protocol. I find this to be a bit troubling because the endpoints seem quite binary and uninformative in terms of shedding light on the MOA.
S/C Protocol Link: https://clinicaltrials.gov/ct2/show/NCT04347239
Dr.BP also described the FDA as being a statistical analysis-based organization and that they don't have the time or inclination to research papers on drugs they are reviewing. He was very clearly discounting the value of his peer reviewed paper in terms of influencing the FDA's approval process in our favor. So, again, this important part of the story will not be exposed to the FDA, or the media (unless the media digs-in to find it -- which will rarely occur in our attention deficit, soundbite world).
I suppose future COVID trials (PrEP, Long Haul, Competitive 3-Arm) might include this level of granularity, but I admit to being disappointed that we don't have the opportunity to tell this part of the amazing story right now.
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