Great discussions and debates ! Thanks to those with better insight as to what might be happening in the various boards rooms and FDA corridors.
I found the following in the August 29, 2023 2QFinancial Statements:
Question, who is be on the Board of the DSMB? If these independent members reviewed and confirmed the findings ... would they not be liable if the statement were not true?
"Serious Adverse Events
For 60 patients treated in Study II, there have been 9 Serious Adverse Events ("SAEs") reported:
- 1 - Grade 1 (resolved within 1 day)
- 2 - Grade 2 (resolved within 1 and 1 days, respectively)
- 3 - Grade 3 (resolved within 5, 80 and 107 days, respectively)
- 2 - Grade 4 (resolved within 6 and 8 days, respectively)
- 1 - Grade 5
Theralase® believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device, as reviewed and confirmed by the independent Data Safety Monitoring Board ("DSMB")."