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Whosetosay

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Whosetosay

Re: None

Thursday, 02/26/2015 8:12:51 PM

Thursday, February 26, 2015 8:12:51 PM

Post# of 80490
Lax appears on track. BTD notwithstanding, the clock to approval starts, depending on the drug, only after an NDA, or BLA is submitted and/or other requirements met. For Ponatinib, it was an NDA.

There are several paths to accelerated drug approval.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

Ariad could be submitting BTD/BLA way ahead of when they said they might start.
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