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Posted On: 09/09/2019 2:43:33 PM
Post# of 149263
SJ , sound OK ,,
FDA will need then different dose safety profile , and information about
Receptor Occupancy Test ( ROT ) .....but why will they delay if this will be it...
To my knowledge , by now they have safety data with 350 , 525 , and 700 mg ..and they have information about ROT....( but who knows , maybe they will need longer time to review this data before accepting ???)
But to me it sounded they want something more , but I really don't know what ....must be not to bad if Q2 of 2020 as earning stay the same ..
And we will see very soon, look like ...
FDA will need then different dose safety profile , and information about
Receptor Occupancy Test ( ROT ) .....but why will they delay if this will be it...
To my knowledge , by now they have safety data with 350 , 525 , and 700 mg ..and they have information about ROT....( but who knows , maybe they will need longer time to review this data before accepting ???)
But to me it sounded they want something more , but I really don't know what ....must be not to bad if Q2 of 2020 as earning stay the same ..
And we will see very soon, look like ...
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