Theralase Technologies Inc. V.TLT

Q about BTD

[Oilminerdeluxe]

My buddy and I had a little query (Hello Jens). I read somewhere: "The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy."

Does that mean we can apply for a BTD approval with the 3 month numbers if they are good enough? Or do we have to wait a full year (12-15 months) before such a thing is possible? Since the optimized patients still have a long way to go until they are at 12 months, we sort of debated if we have to wait another ice age, or if we could already be in a possible time zone where TLT can apply for BTD any day now?

Anyone with a thought to share on this?
Thanks.

[wildbird1]

Oilminerdeluxe..Good question. On the fda.gov/regulatory-information/frequently asked questions-BTD (#23)... (Quote) The review division(FDA) will make a recommendation as to whether a request for a Breakthrough Designation is appropriate, may be to preliminary, or does not currently meet the criteria for BTD. (End of quote). Meaning it is the FDA that decide if it is to soon or not. On year

[Rumpl3StiltSkin]

I think it is clear if the CR data continues to come in as good as it has, so far, we'll have a path to BTD soon. Another cohort of patient data, in the next Quarterly? Very possible.

[Oilminerdeluxe]

Thank you, Rumpl and Wildbird. Maybe the wait is not as long as I feared. So if we have a solid update next time, then we should be well on our way.

[greaterfoolFred]

I am sure that the FDA will want to see results from patients treated at several different locations.  How many locations are now treating patients?  I only know of one.  Or have I missed something?  Wouldn't there be a news release for treatment in a new site?  Our day will come, but let's not create false expectations.  Good luck all.

[Rumpl3StiltSkin]

Yep, I'm betting, literally, that the numbers wil be solid next Quarterly, which leads to the discussion on BTD with the FDA. Which will probably be brought up by the FDA. :-)

[wildbird1]

Forgot to mention.... Last year FDA gave TLT Fast-Track Designation with only 12 patients treated and a CR%(Complete Response ) of just 25%. Today TLT has 18 Optimized patients treated (50% more patients treated than last year 12 patients), and a CR% potential of 94.4% (278% more CR% than than last year 25% necessary for Fast-track designation). The FDA can give BTD(Breakthrough Designation) if

[enriquesuave]

Nice post Wildbird.  I believe that the company has stated that after 25 patients they would file for BTD, and recently Vera commented "soon" .  So clearly they can now as they have perhaps received data from patients 24 and 25 who have hit at least 90 days.  We have strong efficacy signals and also also pointing towards strong durable efficacy results IMO.  That may

[patience69]

BTD would be awesome & so would moving onto another exchange. Isn't the most important pending event really some sort of a partner? Maybe news will just be bang bang bang as some sort of a funding source will likely be necessary to let any of these things happen. I don't know about you but I bet that those negotiations are ongoing. All my best guess mind you 

[CancerSlayer]

Enriquesuave wrote: "Nice post Wildbird.  I believe that the company has stated that after 25 patients they would file for BTD, and recently Vera commented "soon" .  So clearly they can now as they have perhaps received data from patients 24 and 25 who have hit at least 90 days.  We have strong efficacy signals and also also pointing towards strong durable efficacy

[Infinity]

I agree with Enrique,  we are close to submiting the application for Break through designation.  I tried to gather some info from the FDA web page re BTD application process.  Appears straightforward.  The qualifer would be a significant "UNMET Demand" should exist for this type of cure or treatment.  I believe TLT would meet this criteria of unmet demand and the

[robertshaw]

Agree with Infiity. It's in fact the great honor of FDA to grant BTD to us....ASAP ( I amexpecting before Next May). Otherwise I see no difference betwween FDA and our old friends--Blowjobjoe's bosses.

[robertshaw]

No other medical treatment technology in human history could  ever achieve the height of TLD1433.  It's also "great hornor" of  blojobjoe's bosses that almost beated this brilliant technology to death... but, anyway, we survived. So, it's quite safe to say now"Blowjobjoe's bosses '  days are numbered..."