Theralase Technologies Inc. V.TLT

Once pre-BTD was submitted

[Corvette65]

To the FDA in the required format what is the clock for a response

[Kayz88]

60 days upon submission. Based on the earnings call, they'll do a follow up at 30 days (End of December) and hopefully a green light from the FDA for a BTD submission in January. Q12025. Which takes another 60 days for them to yay/nay the submission.  . Mind you, it's UP TO 60 days. So it may come earlier. But given it's the holidays, it'll most likely take the full

[Oilminerdeluxe]

Any chance FDA says. 'No sorry, we want you to do a Phase 3 trial. We changed the rules'..?

[Kayz88]

So I am considering the following - The FDA said they only need a Phase 2 with 20-25 patients - TLT's drug compound and activation is novel - There's an unmet need for this form of bladder cancer - The sponsor hasn't changed yet - There hasn't been any SAE that would've raised any red flags I would conclude that the likelihood of needing a phase 3 is low, but not zero. 

[2b7f6fab]

Sort of doubt the FDA would require a phase 3.  The FDA were the ones who insisted Theralase only treat patients who have already failed BCG and no options left for them.  So Theralase would fall under the umbrella of serious conditions that fill an unmet medical need.

[Oilminerdeluxe]

Thanks. Just trying to figure out if something like that could be the cause of our not so funny market cap. Probably not then. Good to know.

[Sosak1]

This is a new FDA commissioner and if Theralase stiil have a problems with FDA we will have co contact him about it. https://profiles.hopkinsmedicine.org/provider/martin-a-makary/2701414

[tdon1229]

When Study II was being set up (back before the pandemic and shutdown), it was explained that only a Phase II trial would be required.  However, if successful, then in lieu of the Phase III trial, Theralase would be required to keep a registry of all patients up through 300 in order to verify that the initial results from Study II are being maintained as the drug goes into general use. This

[Legit62]

With all these pre-BTDs you would think we get approved in a short time