Thursday, January 13, 2022 7:13:22 PM
Red-(or anyone else here)--could you please remind me what PDD news we have been waiting for---" we could get a nice unexpected PR on PDD/PD any day now, it is beyond overdue."--I thought we have received results from this study--are we expecting more results which have not come out yet ?? it's been awhile and this info has escaped me 1 TIA
We are expecting a third party review paper of the PDD/PD data, it seems overdue to most here. We know it is going to be a good report since the placebo cohort continued to decline, and the low dose cohort did not decline, and the high dose cohort improved, which has never been achieved by any other drug. It also clearly shows dose dependence. Then there is the data showing motor improvements for PD which again no other drug has achieved. Safety data was excellent which is always the top concern before FDA issues an approval.
More importantly is the communication between Missling and the FDA for guidance of how to proceed from here has not been revealed yet.
A2-73 clearly looks like a winner for PDD/PD and highly likely to be FDA and TGA approved, especially since there are no current drugs that comes close to the outstanding PDD/PD trial results.
This is a terrible disease world wide, and the need is great to help these millions of suffers. I hope FDA agrees to speed the process along, because of the excellent trial results and the great need.
I think this could be surprisingly good news once released.
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