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Re: frontiers post# 2790

Saturday, 04/01/2017 5:22:33 PM

Saturday, April 01, 2017 5:22:33 PM

Post# of 21531
Frontiers, yes that was the change in the study design I was referring to.

As to why it suggests a positive Ph2b outcome I’ll explain my reasoning this way. First I will narrate a conversation I had with a private placement investor in NTRP.

When doing his due diligence he approached the CEO of another company also involved in AD research who he knows well. Among the topics discussed he recounted this exchange.

The question he asked was how difficult is it for a company involved in a FDA sanctioned research project to change the study protocol mid-term? The answer he got was that the study protocol was most commonly changed for safety reasons, usually by a Data and Safety Monitoring Board (DSMB). But to change the study design and length, and to get the FDA to go along with it, there would have to be convincing data presented in conjunction with the design change request. He went on to say that the FDA is desperate to see progress in Alzheimer Disease research and whatever data or video they saw must have convinced them.

Secondly, as I explained in an earlier post, investors in the Private Placements had to agree to sign a Confidentiality Agreement, so they must have been shown trial data that was not publically available.

The last private NTRP placement was way over subscribed. I would surmise that the data was convincing. I believe it could very well have been the same data that was presented to the FDA.
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