(Total Views: 374)
Posted On: 06/26/2025 5:00:49 AM
Post# of 154563
Re: USS JOHNSTON #154498
And I agree with you USS Johnston ,
There is no reason at this point for FDA to ask us for 350 mg in oncology , ever .
But this is same as with 4 doses or 2 doses in Covid , company , CMO , need to ask for a meeting with FDA and present all the facts and previous trials results ,
I honestly think it will not be to difficult to show our prove , we need 700 mg .
Just to present carefully results of our 28 patients with TNBC should be enough ..
It is really very disappointing for patients and us to deal with 350 mg during every oncology trial knowing it is not working for our patients .
IMO
There is no reason at this point for FDA to ask us for 350 mg in oncology , ever .
But this is same as with 4 doses or 2 doses in Covid , company , CMO , need to ask for a meeting with FDA and present all the facts and previous trials results ,
I honestly think it will not be to difficult to show our prove , we need 700 mg .
Just to present carefully results of our 28 patients with TNBC should be enough ..
It is really very disappointing for patients and us to deal with 350 mg during every oncology trial knowing it is not working for our patients .
IMO
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