Rharb, - yes , you got it.. There are 3 parts o
Post# of 154845
(Total Views: 599)
Posted On: 04/18/2020 2:14:50 PM
Rharb, - yes , you got it..
There are 3 parts of BLA , first part was submitted in March 2019
--Now we need to submitted part 2 , clinical ,
--and part 3 manufacturing..
It couldn't be done in 2019 , because FDA requested safety patients with 525 and 700 mg for 24 weeks.. We had for 350 mg.
And for manufacturing part they requested stability for 350 mg - 2.4 ml ,
until than we had for 175 mg.
Normally FDA is looking threw BLA after all 3 parts are submitted , but last year they granted to cydy , Rolling Review , so each part can be review separately .
Most probably there will not be a problem with our BLA , since FDA was reviewing each part already many times , each time asking for some clarification and extra information.
We have for combo HIV FTD so approval should be within 6 months.
Since they looking so many times at all our information for the last year , I am hoping we will have approval within 3 months after BLA will be submitted ...
But that's just my opinion.
There are 3 parts of BLA , first part was submitted in March 2019
--Now we need to submitted part 2 , clinical ,
--and part 3 manufacturing..
It couldn't be done in 2019 , because FDA requested safety patients with 525 and 700 mg for 24 weeks.. We had for 350 mg.
And for manufacturing part they requested stability for 350 mg - 2.4 ml ,
until than we had for 175 mg.
Normally FDA is looking threw BLA after all 3 parts are submitted , but last year they granted to cydy , Rolling Review , so each part can be review separately .
Most probably there will not be a problem with our BLA , since FDA was reviewing each part already many times , each time asking for some clarification and extra information.
We have for combo HIV FTD so approval should be within 6 months.
Since they looking so many times at all our information for the last year , I am hoping we will have approval within 3 months after BLA will be submitted ...
But that's just my opinion.
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