Replies to post #4174 on Grapefruit USA Inc (GPFT)

[wadespy]

You have just asked the riddle of the ages.

[AOK11]

Hi Marnyen - I'm not sure but I don't think the pdufa applies to 510(k) applications. As to the date for approval, we were told the FDA has two weeks from the date of receipt (10/8) to provide a response. So I guess we should know something by the 22nd.