RE:RE:Here we are againThe way that I look at Pre BTD is just to clear up the Gray areas if any. It is not a process of elimination, it is a process of consultation before the actual BTD application. This is to make sure that BTD applications have merit and it is a more rigorous review of data to ensure the TLT/ Rutherin meets an Un-met need. The critical word is un-met need, if there is an existing drug/treatment that meets the need for the care of NMIBC BTD applications could get declined. One nice thing is all BTD applications have a 60 day answer period. I am assuming that TLT has already applied for BTD based on their discussions with FDA. Another nice thing is that TLT data so far for the cure, duration of cure, efficacy, cost effective and adverse effects are all superior to existing cures.
The first line of defence would be TURBT which is surgical removal of the cancer cells. This is followed by BCG and or Chemotherapy. When the cancer cells re- appear after this the only treatment is the replacement of the bladder. Cystectomy which is a complex surgery of removal of the bladder and reconstruction of the bladder, has so many side effects many patients do not make it through the cancer or the side effects like rejection of the reconstructed bladder. TLT data should get us through to BTD and even Accelerated approval which is more of a conditional FDA approval that TLT data actually works on a larger population and lives up to its initial data submission. I am not thinking more about BTD, but hoping that FDA would have the foresight to grant AA. Another nice thing about Accelerated approval is that TLT can actually start charging the patients and generating revenue. NO more PP's