RE:RE:RE:RE:RE:RE:"impressive, paradigm shifting, photodynamic therapy" Donein25 ... That's exactly what I have in mind. 9 new sites to satisfy Accelerated Approval new criteria.
On the other side, because we're halfway into this pivotal trial, adding 9 newxx ce sites after Breakthrough designation could also be a legitimate decision from management to accelerate the pace of enrollment in order to complete this trial asap.
But my flair tells me that Accelerated Approval is very possible, if we add 9 more sites too.
Interesting times ahead, that's for sure. No matter the scenario. The FDA doesn't have much arguments to refuse us Accelerated Approval, given:
- the only 2 doses treatment
- the above than competition efficacy results
- the low toxicity
- the organ sparring opportunities for patients
- the non-reliability on BCG
- the possibility to add a 3rd or 4th doses, if needed
- the durable response (when it works, it works for a long time)
- etc ...
_________________
Donein25 - (2/23/2023 6:25:28 PM)
RE:RE:RE:RE:RE:"impressive, paradigm shifting, photodynamic therapy"
Lets keep in mind AA criteria have changed recently. Now most all applicants must show that they have confirmatory trial in place, and in some instances even patinet enrollment. My mind keeps coming back to these new 9 sites. What is their purpose? Perhaps this senario: BTD for 25 patients at 450 in coming weeks/months; AA by end of year after submission of additional 450 data, (say an additional 20-25 patients); then use 9 additional sites to help complete total enrollment by end of 2023. Our completion of the trial with 450 day serveliance can then serve as our confirmatory obligation to satisfy full FDA approval late 2024 or early 2025.