74 Day Letter

[rak5555]

I have confirmed w/ IR that the clock started on 74 day letter on date of filing (10/14) versus date of FDA acknowledgment (10/31). This establishes December 28 as "deadline" for FDA letter. As I understand it, the deadline is the outside date by which a response is due so we could hear something sooner. It is possible, based on Matt's comments at last CC, that a clean FDA letter (no panel, no add'l data/studies) could be final hurdle to finalizing partnership.  Lets just hope Marty doesn't decide to write another letter on Christmas.

[alethea]

To rak5555 - would please expound a bit on what a 74 day letter is or what it does? I followed AMLN for years and now MNKD for a couple of years but have not heard anything about a 74 day letter. If you have time and are so inclined, thanks much!

[rak5555]

Thanks for asking because it made me do a search and I found this excellent site: www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm127153.htm

[alethea]

Nov 21, 2013 12:32:15 GMT -5 rak5555 said:

Thanks for asking because it made me do a search and I found this excellent site: www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm127153.htm

Very informative.  Thank you!