As it has turned out, Prana's method could not have been slower or more costly. It goes without saying that the continuing losses mounted up on Prana's financial statements quarter after quarter to this depressing point. There was no explanation from Prana of the reason that no clinical trials were instituted during this period for Parkinson's or other diagnoses which were not included in the PCH, according to Prana's meager communications.
After months of procrastination, they finally hired a group of "experts" to assist in convincing the FDA of what they had been attempting to convince others of all along: that PBT2 was safe beyond a doubt despite PBT2's composition being an analog of clioquinol with its troublesome history in human use. BUT at the time of completion of Phase II, Prana came up with the idea that it would be helpful to increase PBT2 dosage beyond the highest dose given in Phase II, for the sake of efficacy. As we know, the FDA scientists disagree.
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- Ann: Prana provides regulatory update for PBT2-PBT.AX
Ann: Prana provides regulatory update for PBT2-PBT.AX, page-57
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