RE:RE:RE:« interim analysis » and « successfully treated »Good point CancerSlayer...
This link seem to prove that you are correct
https://pubmed.ncbi.nlm.nih.gov/28420989/ If you read the abstract paragraph you can see that the approval timeline can be as low as 145 days, it does seem that the timeline is the prerogative of the FDA.
Approval could be in a few days...week...months..only the FDA know.
The fact that TLT treatment has a high CR%(could easily be over 70%) and TLT treatment has a very low toxicity will play in favor of TLT treatment.
It is much easier for the FDA to approve a very low toxicity treatment, because a very low toxicity treatment does not cause serious problems for the patients if it doesn't work.
Also we must not forget that the treatment is done in a few hours and the patient goes back home the same day (no big hospital bill $$$$) and the patient goes back to work a few days later(insurance company will love TLT treatment).
CancerSlayer wrote:
skys1 wrote: ScienceFirst, That is a great description of what our position could be. That level of efficacy not achieved before in NMIBC, such ease of treatment, along with "virtually no side effects", what company would waste their time and money trying to trying to compete with something as effective as TLT's ACT. I hadn't thought of it in those terms. Why this company isn't already several dollars is beyond me.
Healthy discussion/debate is always welcomed. As per the FDA....
"A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies."
The key words here are "preliminary clinical evidence" which is based on a clinically significant endpoint (I.e. CR rate at any time). It is my understanding that a BTD is simply based on efficacy "signals" & is thus primarily reliant on CR rates, not durability. There are many examples of previously FDA approved treatments that received BTDs based primarily on the CR rate (often 90 day data)...& were granted before there was significant durability data available (i.e. < 360 day data), & well before any median duration of response could even be estimated. I believe the company running the N-803 + BCG combo trial received BTD status based primarily on 90 day CR data in only 7 evaluable patients. The requirement for a Fast Track designation on the other hand is significantly less, & it can be based solely on preclinical data in select cases.
My perceived threshold for a BTD in our case is simply 20-25 patients (as per previous FDA guidance) showing a promising CR rate at any time. This may require 270 day data in some & perhaps additional data in "fully optimized" patients (I.e. 20+ patients) in order to get a clearer picture of both the safety & efficacy of our updated protocol. I also suspect a lot of patients hadn't been enrolled/treated in late Dec through Feb when the incidence of Covid was higher. If due to the above, any reasonable delays are welcomed...& such a delay can help explain the BTD timeline presented in the 2/7 corporate presentation (late 2022).
JMO. Good luck...