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Posted On: 11/25/2019 5:56:44 PM
Post# of 154147
Correct Misiu,
But we mustn't forget that the safety for 525mg was good (the BLA application was ready in September), in the VERY unlikely scenario that 700mg safety is inferior we just file with 525mg.
FDA required 700mg in basis of the excellent data we had with Mono, so it should be "a stroll in the park", but, to play devil's advocate, each way we are safe, aren't we ???
And remember, NP words in regards to FDA letter :" FDA wants to ADAMANTLY approve" (I bough more shares the next day in basis of that
)
But we mustn't forget that the safety for 525mg was good (the BLA application was ready in September), in the VERY unlikely scenario that 700mg safety is inferior we just file with 525mg.
FDA required 700mg in basis of the excellent data we had with Mono, so it should be "a stroll in the park", but, to play devil's advocate, each way we are safe, aren't we ???
And remember, NP words in regards to FDA letter :" FDA wants to ADAMANTLY approve" (I bough more shares the next day in basis of that
)
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