What to hopefully look forward too, page-19

Look at: https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program

The main thing in the FDA is that a drug will help the patient. 201 study targets the symptoms of the patient as does the 202 survey. If there is an improvement 434 will be approved, IMO. No phase 3 is needed. A drug needs to be safe, of course.

We got early signs of improvement ( 43% and 29%) and this is happening when only 50% of the estimated needed healing time ( 12 months) has passed supported also by MRI volumetric results. Nobody will do phase 3 with ATH434 using hundreds of MSA patients. But in PD phase 3 is needed, IMO.

This is just my opinion when reading FDA instructions.