RE:RE:Q about BTDwildbird1 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.
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.