Hi Solusnauta
Claro mi amigo.
FDA approval is not required in order to commence the new Phase 2 trials, it's a company decision.
The FDA would have no means of knowing how current OC trials are going, other than the results that are published by the company and released to the market. Even PRR has no actual hard data on the patient progress until the end of the trial, at which time the analysis is completed by the testing facility (a contractor). Prima then has to release this immediately to the market under disclosure rules.
prr in trading halt, page-38
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