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Alias Born 10/07/2019

Re: None

Monday, 10/07/2019 10:39:43 AM

Monday, October 07, 2019 10:39:43 AM

Post# of 8923
new to board. interesting company. Was curious if folks have any thoughts on 9 and 12 month data. My general understanding is that the need to present 12 month data to FDA. Little disappointed that there was no mention of this data.

I recall listing to a webinar where CEO stated that patients that had been treated at 9 and 12 (maybe 2) were "following there own natural history" which may be viewed as good in that if they were improving or stabilizing (if that is what she meant).

Not sure, but again surprised no mention or questions on 9 and 12 month data. Reading between the lines the PRs seem more "bullish" on FDA meeting and they now seem to mention accelerated approval more.
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