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Re: Steady_T post# 260055

Monday, 07/20/2020 4:20:08 PM

Monday, July 20, 2020 4:20:08 PM

Post# of 459474

Remember that a P2 trial is normally followed by a P3 trial so there is nothing out of the ordinary if one is required so no need for an 8K




You are right that is true. However, in this specific case if a P3 is needed then this could be considered as a failure on primary endpoints enticing an immediate PR or 8-K.

But Im on skin ICE here I admit


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We would probably share this with regulatory authorities and seek guidance how this data could be then leading to moving this forward towards approval since Parkinson's disease dementia has not received yet a drug which seems to be utilized in the community. There's only 1 drug approved, which, however, does not get used because of significant side effects, that will be the next step.

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