Replies to post #3771 on Theralase Technologies Inc (TLTFF)

[JMoriarty]

All I read from fda website was that it's 60 days for a response to applications made as an 'add-on' or included in the IND.

That's where the 60 days comes.

What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA FAQ
22. FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.



21. Can a sponsor submit a request for breakthrough therapy designation to a pre-IND?

A sponsor should submit a request for breakthrough therapy designation with the submission of a new IND, or as an amendment to an active IND. Requests for breakthrough therapy designation should not be submitted to pre-INDs, inactive INDs, or INDs that are on partial or complete clinical hold.


So the IND will lift the clinical hold.. and start that clock.. i have no clue on the 'results---granted' paradigm is in play or what the standards are.. if 20 or less?

would be a nice though to get the btd granted fully but again.. i dont know if that's even possible?

lol next quarterly is in July. With Mid May being a potential 'update'