RE:RE:Multiple thoughts.Q30.
with all your brilliance, you must have a PhD.
you should apply for the CEO
or perhaps you are just another FUDster taking portions of statements out of context.
You are correct , the additional biomarker studies, were suggestions.
they were/ are also backed by the potential pharma partners.
They did an online video update, with various KOL, at the time.
Amungst all of them, leading to the biomarkers was considered a good utilization; of time.
The only reason the say " potential " , is because the FDA has not yet approved, as part if the phase 3 trial.
Closing the loop of my post.
The biomarkers have clearly been proven & identified.
they have asked FDA to allow them as part of phase 3 design.
once thst answer is received, they will have a complete set up of phase 3 design.
Not sure IF you have ever read a FDA trial/ study design?
lots avsible.
FYI, The page of exclusions. Meaning what a person can or can not have as precondition, is 2 pages long.
The requirements, agsin, multiple pages of checks & balances.
i was part of a phase 2b trial years ago. Nothing at all to do with cancer.
The pre- qualification interview was two hours & thst was after filling out many pages of medical history
point?
When the FDA , outside agencies & medical advisors recommend something, good mangement will listen.
an improperly designed trial can fail. Just on the study itself.
de- risk? Involves addressing all forsesble issues ahead of time.
Thst takes time,
Two ways to do everything the right way & twice.
They want Pela approved. Proper trial design.
the biomarkers, give a huge advantage . Being able to pre- screen the non- responders.