RE:RE:RE:RE:RE:RE:RE:"impressive, paradigm shifting, photodynamic therapy"
CancerSlayer wrote:
Donein25 wrote: 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.
The timeframe to a traditional approval shouldn't change significantly, whether it comes via an AA that is later converted to a traditional approval (that is...post obtaining successful confirmatory data from the remaining 50+ patients) or comes via a more complete Ph 2 study (I.e. after a total of 100+ patients treated). The advantage provided by the AA comes in the form of both earlier treatment recognition & commercialization...two big advantages that we hopefully can take advantage of in order to maximize value prior to finalizing any jv arrangement.
Dr. Mandel's comments in the recent interview for BioTuesdays..."expects to commence partnering talks with large pharmaceutical companies in 2023 / 2024 to commercialize the technology for BCG-unresponsive NMIBC CIS."
The above suggests to me either an anticipated jv pre-AA & post-BTD or he is anticipating strong potential for an early AA pre jv. JMHO.
An interesting article published in Regulatory Focus (8/10/2022) reported that 50% of AAs converted to traditional approvals, & the conversion rate has increased significantly in the past decade....30.5% of AAs over the last decade converted to traditional approvals at a median of 2.3 years, which compares quite favorably to a median of 3.2 years over the entire timeframe studied (1992 to 2021).
Bottom line (from a clinical standpoint)....the AA pathway has provided countless patients with an opportunity to beat death or undergo a much worse alternative when no other reasonable therapy existed.