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doingmybest

02/04/17 8:38 AM

#472 RE: XenaLives #469

Xenalives, I cannot say I have been close to NTRP, but, I have contacted them multiple times and now they have an IR person as before it was their CFO. In recent months they have shifted from a staff of a few to a much more robust organization with new needed skills and focus. They are not complete but now they have sufficient cash to build out a little. They have deep technical needs due to their supply chain and dosage form. If their P2b pans out obviously they would have more than enough cash to invest with, and, they would probably have time constraints to line up their supply chain with commercial regulation and volume requirements. But, they are all exciting challenges to have as long as they are manageable with time, money and expertise. The key obviously is P2b results, then on to all the details of commercialization and P3 confirmation. I would have to believe they would seek a BT designation from FDA and the possibility of AA and PR,... They have stated they will read out top line in April but I just saw where they were not fully enrolled, so, I have to think April is in jeaopardy and maybe a month or two slippage may occur if the number I saw of 119 enrolled was accurate.
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doingmybest

02/04/17 8:44 AM

#473 RE: XenaLives #469

Also, keep in mind, though BRNI has the feel of an academic institution, it was established for a reason and with a focus, which caused it to function like a BP focused research dept. from what I saw, which made them a viable research entity, which had the latitude to extend from basic research to applied science in this single field of memory, which they early on postulated had a key role in AD, which was their primary mission to solve. So, I would conclude that they were not your typical academic type of research endeavor, which can be argued at times tend to be more publication oriented than pragmatically applied real data and solution focused results.
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doingmybest

02/04/17 8:50 AM

#474 RE: XenaLives #469

NTRP is lucky on the patent front due to their API synthesis work if the compound works in humans as it does in animals. These types of supply chains are hit or miss and the FDA will spend considerable time reviewing the synthesis work as it has major implications and the company will have to prove it is equivalent to the natural substance in many respects with the usual safety elements being critical, degradants and contaminants. This is no small undertaking as I said before, but, with a disease like AD, it is certainly more than worthwhile. In my opinion if they decide to partner for P3, which is likely, their partner will assist in this development area considerably as well.