Thursday, January 13, 2022 6:17:40 PM
raja, this is my main question. That said, we could get a nice unexpected PR on PDD/PD any day now, it is beyond overdue.
Since the low dose cohort did not decline and the high dose cohort got better, which no drug has ever done for PDD/PD, it appears to be a win with FDA approval.
Also the motor skills improved for the secondary end points for PD, again no other drug has ever achieved that, another reason for FDA approval.
It is highly likely that Missling has been in talks with the FDA as to how to proceed from here to FDA approval. This could be a nice surprise.
BYW schizophrenic is certainly not a rare CNS disease. Maybe the undisclosed rare disease has not been revealed yet. Didn't he say it would start off as a Ph-2b/3?
Since the low dose cohort did not decline and the high dose cohort got better, which no drug has ever done for PDD/PD, it appears to be a win with FDA approval.
Also the motor skills improved for the secondary end points for PD, again no other drug has ever achieved that, another reason for FDA approval.
It is highly likely that Missling has been in talks with the FDA as to how to proceed from here to FDA approval. This could be a nice surprise.
I know that there are valid reasons. But still hard to believe that 16 months after that encouraging PR about PDD, there is absolutely no news about any further development. Even PDD OLE is supposed to be done (going by the timeline)
Missling prefers to keep mum is probably a good assumption; just like that unannounced CNS disease - or was it the recently identified Schizo ? Not very clear or may be I am missing something.
BYW schizophrenic is certainly not a rare CNS disease. Maybe the undisclosed rare disease has not been revealed yet. Didn't he say it would start off as a Ph-2b/3?
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