Theralase Technologies Inc. V.TLT

Here we are again

[Dumbeldorfwhite]

No update on the Pre BTD application which realistically could me the FDA could have asked for more data.

[McBullish]

Were we told we would be updated when Pre-BTD went into the FDA? Further, were we told we would be updated with a response once the FDA responded with guidance? Is it normal to have this type of update with a biotech company or do we just get updated once there is actual new deisgnations assigned?

[zombize]

This was the reply i receibed last week when inquiring about BTD: "As of our October 7th press release, we have submitted a pre-BTD with the FDA.  We are now in consultation with the FDA regarding submitting a BTD application.   We will update the market on our BTD status once we have something material to report." Presumeably, having the pre-BTD rejected

[McBullish]

Thanks for clarifying. I ask these questions because I am unfamiliar with the process and associated timelines. Theres a lot of speculative BS, both positive and negative, posted on this board and I am trying to get a handle on the likelihood that BTD would be assigned. If our Pre-BTD was accepted or had minor revisions requested, what is the percentage chance of BTD approval?

[Eoganacht]

"Presumeably, having the pre-BTD rejected would be s material development, no?" I don't think a pre-BTD is "rejected" as such. It is not an application for something, it is merely a consultation about an application. The review division makes a recommendation about a sponsor's BTD application, not a decision. Theralase's Ruvidar PDT has been granted Fast Track

[Maxcitrac]

Eoganacht, here is complementary informations to your post. This is an extract from the email that was send to investors by Matthew Perraton about a PP, 14 days ago. This a quick offering as we are not looking to do a large raise at this time. We feel that we will be able to do a larger capital raise early 2025 at a higher valuation. This extract indicate that Theralase is confident that all the

[Kpain9999]

Has the actual BTD application been submitted?  It doesn't seem like it or they would have said so.  So I hope they tell us when the actual BTD app is submitted.  I could be wrong.

[enriquesuave]

My guess is if we hear about it , it will be on next update or within next news PR

[Legit62]

It appears they need small amount of money until BTD approved which looks very high at this point, most likely anytime before year end. Could be any day now IMO, does not necessarily take 6 weeks, FDA say the response time can be up to 6 weeks

[charlierock]

Once a company applies for BTD, the FDA has to respond within 60 days. Not 6 weeks 

[Legit62]

My error,meant 60 days, still believe we hear soon

[zombize]

Point taken, poor use of the word 'rejected' - but, my point remains; wouldn't any response regarding pre-BTD recommendations that led to a signfiicant delay in the formal BTD application be, in itself, a material development? To paraphrase you, I don't think Theralase is obliged to report every single snag to it's shareholders, but, as regards pre-BTD/BTD, I'm sort of of

[Infinity]

The way that I look at Pre BTD is just to clear up the Gray areas if any.   It is not a process of elimination, it is a process of consultation before the actual BTD application.  This is to make sure that BTD applications have merit and it is a more rigorous review of data  to ensure the TLT/ Rutherin meets an Un-met need.  The critical word is un-met need, if there is an

[DJDawg]

I've always assumed that pre-BTD was a process to thin out the applications for BTD. Otherwise everyone would apply (why not) and then the reviewers would have to do an obligatory deep read of a giant pile of documents for EVERY drug in the pipeline.  It makes sense to have a pre-BTD process to save time for everyone. The fact that they had the review and are circling back means, to me

[TommyNickels]

If Theralase got the Green Light, Roger would be blasting this to the world. He's raising what he can at 30 cents. Next PR will be the private placement. Maybe half a million. Next will be Financials at end of November and an update on the study. Hopefully FDA has agreed to lower the total.number of patients. Maybe 80 is good. Then BTD submitted after all patients have 90 days of testing