Disappointing but not surprising. JF to FDA 6 years ago - but the data is fine - FDA we want more trial data, 5 yrs with consultants - how bout it? FDA -we want more data - 4yrs, 3 yrs 2yrs - how bout now? FDA we want to see more data etc - I understand regulatory processes can be frustrating but SPL deserved what they got here IMO.
Current CEO gave the right statement IMO - not point wasting what cash is left on a trial with the current state of Vivagel sales.
We need something with DEP now.
Ann: VivaGel BV US FDA Appeal Outcome, page-11
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