Theralase Technologies Inc. V.TLT

FDA

[O12009]

I was just wondering when a company applies for BTD or AA is this info treated as top secret at the FDA or is it possible that the public could access the info.

[consultant99]

Apparently not...from the FDA Q & As Will FDA announce when a drug has been granted breakthrough therapy designation? FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an

[O12009]

Thank you 99

[Legit62]

I would bet to say on next big NR is we received BTD, and soon after AA, within 1 month