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boi568

04/28/22 6:31 PM

#358816 RE: falconer66a #358814

I am skeptical about the chances of a Parkinson's dementia approval without a Phase 3, but I wouldn't turn it down, either. However, we don't even have a properly controlled straight-on PD Phase 2 PD trial (unlike PDD). We would certainly need a Phase 3 PD trial under the best of cirumstances.
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Steady_T

04/28/22 8:29 PM

#358820 RE: falconer66a #358814

The importance of the safety factor of 2-73 can not be over estimated. There are very few drugs on the market that have a better safety record than 2-73. As you point out, the CNS drugs all have significant side effects