(Total Views: 346)
Posted On: 11/25/2019 6:05:02 PM
Post# of 155808
TechGuru,
FDA really have already results with 525 and 700 mg ,
safety profile on 525 mg ,
so actually they could evaluate very fast , the only new thing for them will be safety profile for 700 mg.
FDA told our company that they like better 525 mg over 700 mg results , but still asked them for 24 weeks safety for 700. This tells me they not sure which dose they will advise them to use at the end .
This statement they want " Adamantly " to approve us , is little funny from FDA, imo
They should approve combo with 81% efficacy on 350 mg 6 months ago , and after that perfect and adjust the dose...
No , there is not a problem either way to approve , but they delayed treatment for very sick patients for 6 months now , it will be about 1 year by next June by the time we be approved ,
and without really any reason.
IMO of course.
FDA really have already results with 525 and 700 mg ,
safety profile on 525 mg ,
so actually they could evaluate very fast , the only new thing for them will be safety profile for 700 mg.
FDA told our company that they like better 525 mg over 700 mg results , but still asked them for 24 weeks safety for 700. This tells me they not sure which dose they will advise them to use at the end .
This statement they want " Adamantly " to approve us , is little funny from FDA, imo
They should approve combo with 81% efficacy on 350 mg 6 months ago , and after that perfect and adjust the dose...
No , there is not a problem either way to approve , but they delayed treatment for very sick patients for 6 months now , it will be about 1 year by next June by the time we be approved ,
and without really any reason.
IMO of course.
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