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Sunday, August 11, 2019 2:48:58 AM
Like any other Biotech CEO Missling would like to beat the study completion estimate entered by the FDA.
The completion dates becomes much clearer as soon as Anavex announces 100% enrollment, which Missling couldn't do in the cc since the studies are not yet 100% enrolled.
As opposed to MB investors, Anavex are not yet aware of the outcomes of the current trials. Therefore it is too early to determine if more studies are needed, what their design might be and what input the FDA might have.
He could have answered those questions a lot shorter and more concisely, so people wouldn't speculate about the meaning of all those words.
Secondly the analyst could instead have used the slot to ask some useful questions, like:
* Do you still plan on enrolling a North American cohort in the P2b/3 AD study and when, triggered by what?
* With the Australian expansion of the PDD trial will the study population now be about 150 (120 + 30) at 100% enrollment and be analysed together at study completion?
* When are you expecting the peer reviewed paper on clinical data will be published?
* etc.
PS! No I am not short and not part of any cabal, just an experienced member of the upper echelon of biotech investors who shares the hope that those trials are 100% enrolled soonest. For all I know at least the PDD trial could be 98.2% enrolled as I write. Also hope that the endpoints will be met, although at this point I remain a little less certain than most and continue to regard the risk/reward relationship as improving.
The completion dates becomes much clearer as soon as Anavex announces 100% enrollment, which Missling couldn't do in the cc since the studies are not yet 100% enrolled.
As opposed to MB investors, Anavex are not yet aware of the outcomes of the current trials. Therefore it is too early to determine if more studies are needed, what their design might be and what input the FDA might have.
He could have answered those questions a lot shorter and more concisely, so people wouldn't speculate about the meaning of all those words.
Secondly the analyst could instead have used the slot to ask some useful questions, like:
* Do you still plan on enrolling a North American cohort in the P2b/3 AD study and when, triggered by what?
* With the Australian expansion of the PDD trial will the study population now be about 150 (120 + 30) at 100% enrollment and be analysed together at study completion?
* When are you expecting the peer reviewed paper on clinical data will be published?
* etc.
PS! No I am not short and not part of any cabal, just an experienced member of the upper echelon of biotech investors who shares the hope that those trials are 100% enrolled soonest. For all I know at least the PDD trial could be 98.2% enrolled as I write. Also hope that the endpoints will be met, although at this point I remain a little less certain than most and continue to regard the risk/reward relationship as improving.
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