RE:RE:RE:RE:Quote by Warren BuffetThere was no need to wait until they got 34 patients treated.
The company was very specific in the conditions that needed to be met to achieve BTD as laid out years ago and reinterated ever since.They needed 20-25 patients with a CR rate of at least 20% at 450 days. That was achieved at the end of August 2022.
The question that continues to baffle me is if getting BTD is a binary event and if you meet the minimum criteria why wait? There was sufficient data after 24 patients to demonstrate an improved CR rate with the 12 patients that received the optimized treatment.
Now some SIX months later still no BTD or even whether the company has made an application.
Maybe as the company has delayed the filing until 34 (or more) patients have been treated.
Maybe the FDA moved the goal posts .. regardless.its all idle unnecessary speculation.
The company said they expect BTD in Q1 2023; I expect them to deliver on this or provide an update as to any timing changes.
While they are at it why not update the corporate presentation and fact sheets on the company webpage that are clearly out of date.