My belief in the FDA has taken a further dive whic
Post# of 72444
(Total Views: 688)
Posted On: 11/12/2021 12:27:41 PM
My belief in the FDA has taken a further dive which surprises me as I had already thought them about useless and close to criminal.
Trials are expensive yet once started they seem to be unable to transform to some degree to attain the best possible/probable results.
Assume the statement is true that the dosage, which I think was limited by the FDA to far lower than what IPIX wanted, was too low to achieve positive TL results than why didn't the review committee allow after the first 25% of patients were done to allow further patients to get higher dosages, or at least allow another arm to get far higher dosages, to see if this was an error in setting up the trial and the dosage was the culprit in B failing to achieve TL. No, they didn't do squat but allow 2 further dosings at the low level which obviously failed to do anything.
The additional arm would have saved IPIX a lot of money in having to do another trial at the higher dosage (would the FDA even allow a higher dosage now? - only if CU shows that critical patients tolerated the greatly higher dosage well IMO) from scratch. LOTS of time and money wasted. So no, I don't look kindly on the FDA. Somehow BP trials don't seem to have this problem, wonder why. Also makes me wonder why they allowed the larger dosage in the CU population, probably because they were near death and had nothing to lose.
My contention is that putting 30 or so people at risk with severe conditions with a higher dosage is well warranted (with their consent) to try and bring about a much quicker end to a pandemic killing tens of thousands. I seem to be in an extremely small minority as to this point.
I agree with you totally for IPIX to partner B-Covid ASAP with a BP to get it off square one. Would really help in advancing quickly OM and IBD.
Trials are expensive yet once started they seem to be unable to transform to some degree to attain the best possible/probable results.
Assume the statement is true that the dosage, which I think was limited by the FDA to far lower than what IPIX wanted, was too low to achieve positive TL results than why didn't the review committee allow after the first 25% of patients were done to allow further patients to get higher dosages, or at least allow another arm to get far higher dosages, to see if this was an error in setting up the trial and the dosage was the culprit in B failing to achieve TL. No, they didn't do squat but allow 2 further dosings at the low level which obviously failed to do anything.
The additional arm would have saved IPIX a lot of money in having to do another trial at the higher dosage (would the FDA even allow a higher dosage now? - only if CU shows that critical patients tolerated the greatly higher dosage well IMO) from scratch. LOTS of time and money wasted. So no, I don't look kindly on the FDA. Somehow BP trials don't seem to have this problem, wonder why. Also makes me wonder why they allowed the larger dosage in the CU population, probably because they were near death and had nothing to lose.
My contention is that putting 30 or so people at risk with severe conditions with a higher dosage is well warranted (with their consent) to try and bring about a much quicker end to a pandemic killing tens of thousands. I seem to be in an extremely small minority as to this point.
I agree with you totally for IPIX to partner B-Covid ASAP with a BP to get it off square one. Would really help in advancing quickly OM and IBD.
(10)
(0)