Without reading the trial specification, I am only surmising. This trial is to establish that vivagel will prevent recurrence (if one continues to take the treatment). So the primary end point is the key one. Participants who get a recurrence of the condition after the treatment period has ended do not invalidate results at the primary end point. That was the subject of the "failed" cure test.
So I think they will be interested in how recurrence occurs during that 12 week follow up period, and if it does. These results could help a FDA cure resubmission.
My thoughts only, biotechcatalyst is the expert.
SPL Price at posting:
61.0¢ Sentiment: Buy Disclosure: Held
