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Sunday, March 12, 2017 11:45:53 AM
You and your miss's may be plus $1,000,000 this coming week.
All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Nader filed on Jan. 11. Question is what date did FDA receive the filing? Receipt starts the clock.
We need to go 2 for 2. FDA thumbs up on BTD and knockout P3 Adjunct PE. PR both pre-market on the same day would be pure bliss. This is possible but maybe asking too much for the same day. You know Nader and Anthony C woukd make this happen if within there reach. That would produce the golden quarter.
I believe the two events may be linked. Can you imagine what the FDA would look like if they granted BTD prior to completion of P3 Adjunct PE and then the trial fell flat a week or two later. Is the FDA wanting that data before making their decision? Just a thought, maybe too much thinking while we are playing the waiting game.
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