It's not a catalyst; the drug is safe and we want to do a phase 3. The FDA guidance will be on how big a trial, qualification criteria, endpoints, etc. They will be sensible.
It will be interesting to see if we actually do it in PDD and/or PD. I would imagine endpoints for both.
"after submitting the results of the study to the FDA to obtain regulatory guidance."
That is the unknown....How long before the results of the study are available? TGD likes to beat this horse to death. Hope it isn't like the first Alzheimer's trial