re: Ann: Complete Response Letter from FDA re...
Not sure how this all works. My understanding is that the "please explain" letter (CRL) means QRX will need to submit a New Drug Application NDA). QRX say they will refile in Q4 2013.
I also understand that the PDUFA date is the date by which the FDA must approve or reject QRX's NDA and that the FDA must do this within 10 months.
If all the above is correct then we may not hear about FDA's approval or otherwise of MOXDUO until Oct - Nov 2014.
Also is it correct that once QRX gets a PDUFA date then the FDA can charge it fees?
Not a holder but watching keenly.
QRX Price at posting:
90.0¢ Sentiment: None Disclosure: Not Held
