wildbird1 wrote: 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 the FDA think that the results will continue to as good or better with more patients treated.
If future data do not satisfied the FDA, the BTD(Breakthrough Designation) can be withdrawn from TLT.
With a CR potential of 94.4% on the optimized patients, not much of a chance of a withdrawal, because of the kind of patients that TLT is allowed to treat(BCG unresponsive patients), from the FDA standpoint with these type of patients a 60CR%(Complete Response) would be huge, and anything over 70% would be jackpot.
Remember in the end it is the CR%(Complete Response) that count, not the market, not the SP, not the manipulation.....
As we speak FDA and TLT could already be discussing BTD(Breakthrough Designation application).
94.4% CR potential....????
wildbird1 wrote: 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 ago FDA gave TLT Fast- Track Designation with a CP(Complete Response)% of just 25%.
Today TLT optimized patients have a CR potential of 94.4%(only 18 patients have been treated).
We must remember that the FDA scientists that read the datas are highly qualified scientists, their experience give them the knowledge necessary to predict the direction and the trend a trial is going.
They can see a lots of thing in data that you and me can't see.
Oilminerdeluxe wrote: 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.