Yes the FDA approval is today and I expecting they get the news tomorrow or Monday next week. Buy pressures will come when they clear-out dumbmoney traders.
What some people do not realise is that 30 days after submission the IND can commence... the only time the FDA will weigh in is if the applicant can commence earlier or if the IND trial is denied.
An IND application may go into effect:
- 30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
- on earlier notification by FDA that the clinical investigations in the IND may begin.
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