Theralase Technologies Inc. V.TLT

FDA Moving the Goal Posts ?

[Kingpin68]

I think the change to the optional 2nd treatment, or 3rd treatment, will be positive for patients and increase CR's.
But why the need for data past 450 days ? Yes, it's good to know obviously, but the FDA couldn't have mentioned this before now ? And will it cause a delay in pre-BTD?
And what's wrong with local pathology results that they need it centralized to 'validate'. While this could be all good news, I hope it doesn't delay things to much.

[Kingpin68]

I suppose the most logical answer is that the company and FDA believe this is a great treatment that can do even better for patients. And if you're going to do a second or third treatment at 360 days or even beyond, then obviously you need to check for efficacy beyond those timelines. This gives them a chance to find the best protocol for patients for commercialization has the phase 2 trial