2nd Phase 3 trial possibly neededThe is the likelihood of the FDA recommending the 2nd Phase 3. Most clinical trials require two Phase 3 trials to be run, typically sequentially and sometimes concurrently. Some trials have a single Phase 3 declared at the start as a pivotal Phase 3. In this case the 1st Phase 3 was not initiated as a pivotal trial.
The first Phase 3 enrolled 129 patients and took 4&1/2 years to complete.
There is a reason the stock price is cheap.