Sunday, July 05, 2020 1:11:04 PM
I think there is a 20% chance that topline PDD results for the CDR-COA primary endpoint will be < 0.05. I think improvement on the UPDRS is very unlikely (< 10%). SDS-CL-25 (sleep) 20-30% chance of < 0.05 .
The topline results may not include the pre-specified results by genetic breakdown as that is not a primary or secondary endpoint. That data will come out later.
I believe receipt of topline results is a very material event and I would expect a PR +/- 3 days after the results are in. It is possible they have results now but I still feel after July 13 is more likely.
These are of course opinions: if the CDR-COA (primary endpoint) is < 0.03 I would anticipate share price jumping to $14 and higher if < 0.01. If results are 0.03 to 0.05 price will be volatile and be a bit higher as we anticipate the genetic subset data. If p = 0.07 or worse, share price may hit 1.25, mostly as investors and analyst will expect a poor outcome for AD as well.
if p = 0.07 or better for CDR-COA in the entire population, I would expect a phase 3 will be planned though the genetic data will help guide details of this. I don't expect PA application even if p = 0.001.
There may be some additional endpoints that come out eventually. Most useful would be ADAS-Cog or MoCA scores
The topline results may not include the pre-specified results by genetic breakdown as that is not a primary or secondary endpoint. That data will come out later.
I believe receipt of topline results is a very material event and I would expect a PR +/- 3 days after the results are in. It is possible they have results now but I still feel after July 13 is more likely.
These are of course opinions: if the CDR-COA (primary endpoint) is < 0.03 I would anticipate share price jumping to $14 and higher if < 0.01. If results are 0.03 to 0.05 price will be volatile and be a bit higher as we anticipate the genetic subset data. If p = 0.07 or worse, share price may hit 1.25, mostly as investors and analyst will expect a poor outcome for AD as well.
if p = 0.07 or better for CDR-COA in the entire population, I would expect a phase 3 will be planned though the genetic data will help guide details of this. I don't expect PA application even if p = 0.001.
There may be some additional endpoints that come out eventually. Most useful would be ADAS-Cog or MoCA scores
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