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07/06/18 3:04 PM

#156301 RE: Amatuer17 #156298

And you know this how????


3. M is working with FDA for precision medicine adaptive trial so AD and Rett trials are delayed (one was debunked as they did not even applied in US for AD)

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Steady_T

07/06/18 3:14 PM

#156302 RE: Amatuer17 #156298

1. Last time Missling was asked about BIIB and MS he said that the material transfer agreement was still in effect and it's been a while since a read that, but I think he said that they were still researching it for MS.

2. Who knows what BIIB thinks about AVXL.

3. We do know that AVXL is working with the FDA on Rett. Whether AD was included in those discussion at one point or not is simply not known. What we do know is that AU has moved forward with AD trials. Whether the FDA is or will take notice of the AU AD protocol is not known.

4. The AU govt. is contributing to the costs of AD trials. So far it looks like by providing resources rather than direct cash. Although there is that rebate thing.

5. If the interim data is very good, they just might approve 2-73 prior to trial completion. We just don't know. That sort of thing has happened in the past. Depends on how much of an effect the genome selection process has on the outcomes. For example, if the selection process results in 25% of the subject having the kinds of recovery results that the strong responders had in the P2ab. I can see early approval. I'm not counting on early approval myself.