That is the problem , company to what I know is re
Post# of 148181
(Total Views: 372)
Posted On: 09/02/2019 9:24:50 AM
Re: HHIGambler #7104
That is the problem , company to what I know is ready to finish BLA as soon as FDA will make a decision what dose they want to approve , 700 mg or 525 ...
Company recommendation is 525...
Company feel that it will happens any moment , but the problem is FDA don’t give a time , when they ready with decision..’
This is why I am giving until end of October.. , not to be disappointed
One thing is when they accept BLA , having Fast Tract Designation and Rolling Review , people who know , telling me that they approving within
3-6 months , so September or October will not change much .,
We should be approve 1 Q of 2020 , and after waiting for so many years this sound good to me !!!
IMO
Company recommendation is 525...
Company feel that it will happens any moment , but the problem is FDA don’t give a time , when they ready with decision..’
This is why I am giving until end of October.. , not to be disappointed
One thing is when they accept BLA , having Fast Tract Designation and Rolling Review , people who know , telling me that they approving within
3-6 months , so September or October will not change much .,
We should be approve 1 Q of 2020 , and after waiting for so many years this sound good to me !!!
IMO
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