RE:RE:RE:RE:RE:RE:I am almost convinced there's been a pushI disagree with your assumption that the most logical explanation would be that they want to include the most optimized patients in such FGDA application. At least I hope not...
The company is in constant contact with the FDA and has not waivered in their communication to shareholders that the plan was to submit data for the first 25 patients in their application for BTD.
As I previously posted there is now sufficient information by which the the FDA can see the results of the first 13 patients (12 of which were undertreated) and the next 12 patients all with the optimized treatment.
The group of 25 patients meets the minimum requirement of the FDA as per the company communication to shareholders. The first 13 of the optimized group at 450 days is trending between 35 and 43% based on the information in the November 2021 and 2022 press releases and excluding the 3 phase 1b patients.
It seems more logical to me now to believe the delay in submitting the application could be related to the additional testing of the patients that were IR after 450 days. In addition by waiting until there were 25 patients at the 450 day mark the company can clearly show how the first group of the optimally treated patients compares to the undertreated group.
We know the numbers are getting better and will continue to as more and more data comes in from the optimized treated patients. Hopefully the FDA will as well. The company can at anytime separate the results for the optimized group and compare them to the overall results. Meanwhile the best validation for the companys technology is getting BTD from the FDA, in my opinion.
The next step will be getting AA.
The data coming in from the optimized treated patients, assuming they mirror what we have seen for the first 13, are high enough to warrant getting AA. At what point will theses higher results make a compelling case?
The next trial update hopfully will start to answer these and more questions ...