wildbird1 wrote: Eoganacht, thanks for the clarification...
At first glance Maxcitrac saying that after the Pre-BTD approval, the BTD approval is almost 100% guarantees, looks a little too much.
But! If first we looks at these 6 facts about TLT-Ruvidar...
1)TLT-Ruvidar is the only ''one and done'' treatment in the world with the highest CR% in the class, that treat BCG resistant patients.
2)TLT-Ruvidar has better data than the 3 FDA approved treatments for BCG resistant patients(Keytruda, Adstiladrin, Anktiva).
3)TLT-Ruvidar is the only treatment for BCG resistant patients 100% safe(the FDA love 100% safe).
4) TLT-Ruvidar fill an unmet medical need, by treating heavily pretreated patients that no other treatments can treat.
5)Keytruda,Adstiladrin and Anktiva, with lower CR% and more side effects and restrictions than TLT-Ruvidar, all did receive the FDA BTD approval(you have to like this one).
6) The FDA badly need TLT-Ruvidar.
Now! If you take No1+2 +3 +4 +5+6 and you include the Pre-BTD approval... than the 100% guarantees BTD approval looks a little more plausible.
Although nothing is 100 % guarantees, in the case of TLT-Ruvidar, the data and characteristics are staggering, and pointing toward BTD approval.
I love-------------------------------------------------my morning coffee.
.
Eoganacht wrote: Hi Maxcitrac - preliminary BTD advice is a useful tool but it's up to trial sponsors whether they want to use it or not, although it's hard to imagine why a sponsor would not take advantage of it.
Maxcitrac wrote: Eoganacht wrote: The
FDA BTD FAQ site makes it clear that
preliminary BTD advice is advisory and does not predict the actual
BTD decision.
Frequently Asked Questions: Breakthrough Therapies Question 22. What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.
Question 23. Can a sponsor get preliminary breakthrough therapy designation (BTD) advice from the review division prior to the submission of a formal BTD request?
A sponsor can contact the regulatory project manager (RPM) in the division to which the active IND is assigned and request the “Preliminary Breakthrough Therapy Designation (BTD) Advice Request” template. This template should then be submitted as a formal amendment to the IND and a subsequent teleconference between the sponsor and the review division will be set-up by the RPM. The review division will make a recommendation as to whether a request for a BTD is appropriate, may be too preliminary, or does not currently meet the criteria for a BTD. The Agency’s recommendation is advisory and is not to be interpreted to predict the Agency’s decision on the BTD request. NOTE: A Preliminary BTD Advice Request may be submitted to an active PIND, although a formal BTD request may not be submitted until the IND is opened.
Very good point Eoganacht, I like the highlited part that say's
or does not currently meet the criteria for BTD. Please correct me if I am wrong, but what it does imply is, if all the necessary criterias for the BTD approval are not included in the Pre-BTD application,TLT could have to refile a new Pre-BTD application with the missing informations.
My point is if all the criterias for the Pre-BTD approval have been provided to the review division, then in order to help the SP, TLT could say it in a news release or in an update, as long as the FDA laws permit it naturally.