Ann: Prana Alzheimer's disease data at world leading conference-PBT.AX, page-35

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m123456

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28/07/16

21:48

Post #: 18393190
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Originally posted by xrx2gr0 ↑

When the Prana Chief Executive and Board of Directors announce that they have cooperatied with the FDA by submitting requested safety data that was requested last year you can choose to smear the FDA. The PCH would not have been necessary if it had been proven by the end of Phase II for HD that the trial was properly powered and of enough length to establish safety of the dosage that Prana wanted to use for adequate efficacy of PBT2, a clioquinol derivative.

The onus remains on the Prana Chief Executive and Board of Directors to provide requested safety data in a timely manner (too late now) to aid the FDA in determining to lift the PCH and permit Reach2HD to proceed to Phase III. It may be possible that they did submit inadequate information and the FDA's questions remain. If so, we are not being told that.

The idea of placing the blame on the FDA when they are doing their job for public medical safety of a far-from completely-tested HD drug is not sensible... even less sensible is the inference that favoritism of AD "competitors" and timing to coincide with a medical conference has something to do with this whole unfortunate unproductive mess.

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Please stop twisting truth for your agenda ( whatever that is)

There's been no issue with safety of pbt2 in humans at pranas desired dosage up into me .... We have been told the hold has been initiated due to toxicity on some animal tests which prana now needs to show will not carry over to humans at the required dosage..

Last edited by m123456: 28/07/16

PBT Price at posting: 9.7¢ Sentiment: None Disclosure: Held
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