Z_Smith, Very interesting post. There rare sev
Post# of 155466
(Total Views: 545)
Posted On: 03/24/2021 10:39:43 AM
Z_Smith,
Very interesting post. There rare several aspects of the ROT that we (me for sure) don't understand and you put forward a compelling argument.
It is unbelievable that we are not approved for HIV for 525mg or 700 mg with the efficacy and safety we have shown. Nt to mention the need there is, more so, for experienced patients.
Statistically speaking we met the EP. There is no reason on earth why we should not be in the market.
Apart, of course, of what I believe is the reason. But we have gone through that before and won't go into that rabbit hole.
Enter the ROT: that imo, was an unnecessary ingredient as there are hundreds of drugs out there approved with sub-optimal dosages. FDA requires a good p-value and that's it. Fine-tuning dosages with the current clinical trials structure and costs is almost suicidal.
If one gives bacon to the dog he will not settle afterwards for "good behavior" cookies.
We gave bacon to the FDA.
Now, whose idea was it ??? I have the suspicion that the schism between BP and NP was born there. Not sure about the timing but I think BP might have suggested we test for occupancy (good for business) and NP agreed as this would explain the data variability (525mg vs 700mg) "nailing" the FDA approval.
But it didi not pan out that way and the FDA did not like the way we did it, and NP blamed BP for the idea and the data.
And here we are ... with the dog waving the tail waiting for bacon while the cookie jar is full.
Happy to stand corrected if the time-line does not coincide with the sequence of events.
Very interesting post. There rare several aspects of the ROT that we (me for sure) don't understand and you put forward a compelling argument.
Quote:
My understanding was the FDA, partially based on the arguments CYDY put forth, believed that ROT was the key to unlock these mysteries. CYDY told the FDA that with an accurate ROT, they could precision dose any patient based on their native quantity of CCR5 and also increase dosage whenever there was a spike due to e.g. illness.
From that point forward, the ROT essentially became a validation of CYDY's understanding of the MOA of LL for HIV. If the ROT hypothesis proved out, then all the variables would fall into alignment.
It is unbelievable that we are not approved for HIV for 525mg or 700 mg with the efficacy and safety we have shown. Nt to mention the need there is, more so, for experienced patients.
Statistically speaking we met the EP. There is no reason on earth why we should not be in the market.
Apart, of course, of what I believe is the reason. But we have gone through that before and won't go into that rabbit hole.
Enter the ROT: that imo, was an unnecessary ingredient as there are hundreds of drugs out there approved with sub-optimal dosages. FDA requires a good p-value and that's it. Fine-tuning dosages with the current clinical trials structure and costs is almost suicidal.
If one gives bacon to the dog he will not settle afterwards for "good behavior" cookies.
We gave bacon to the FDA.
Now, whose idea was it ??? I have the suspicion that the schism between BP and NP was born there. Not sure about the timing but I think BP might have suggested we test for occupancy (good for business) and NP agreed as this would explain the data variability (525mg vs 700mg) "nailing" the FDA approval.
But it didi not pan out that way and the FDA did not like the way we did it, and NP blamed BP for the idea and the data.
And here we are ... with the dog waving the tail waiting for bacon while the cookie jar is full.
Happy to stand corrected if the time-line does not coincide with the sequence of events.
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