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Posted On: 12/14/2019 6:35:40 AM
Post# of 149733
Re: Cytodynamite #12663
This is expectation of many. , since this is a very reasonable time to be approve , 6 months after BLA ,( I don’t expect BLA to be much delay , December -January the latest ) ..,
and having FTD and rolling review ,
It may happen sooner since our combo is for drug resistant , very sick patients without many choices .
And actually being that first part was submitted many months ago , and being that FDA is reviewing now tests and results of 525 and 700 mg treatment
, good possibilities that approval will come sooner than 6 months after BLA .
IMO as always ..
and having FTD and rolling review ,
It may happen sooner since our combo is for drug resistant , very sick patients without many choices .
And actually being that first part was submitted many months ago , and being that FDA is reviewing now tests and results of 525 and 700 mg treatment
, good possibilities that approval will come sooner than 6 months after BLA .
IMO as always ..
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