Anders,
You are not on thin ice. Legally or clinically.
These 2 additional aspects of contact make the ice much thicker:
“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.”
The part of the answer where Dr. Missling states that we would next try to move forward towards approval is followed by an explanation of context -
“... 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,...”
This is an industry accepted rationale for early approval: unmet need, based on the lack of any current drug which gets used due to poor side effects.
This statement by Dr. M makes it clearer that he is not looking for a ph3 but wants the unmet need to be the justification for an approval is results and safety are demonstrated superior.
In addition, please consider that the company acted in a way which can warrant an earlier approval: they added 30 additional patients to the approved n, which would be suggestive of a company looking for a signal by increasing n - but why would they if funds are tight and there has already been 100% of eligible patients in an ongoing OLE - being observed for a year?!!
That is the behavior of a company who wishes to support grounds for approval with large enough n in ph2.
Take all of this together with the Dr’s revelation of the next step in the strategy - meeting to move forward for approval and you are on solid ground, legally/semantically, and clinically/statistically.
Thank you for posting your opinions based on your area of expertise - greatly appreciated.
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