It’s possible that the clock didn’t start until FDA acknowledged receipt of the IDE submittal— if that’s the case, the 30 days won’t end til this coming THURS. anyone who sells before the announcement is going to be sorry imo. Most likely case is conditional approval as I’m sure there will be a few remaining questions FDA will have on that much info submitted. Don’t be confused, this outcome would be GREAT news and would likely mean that FDA believes any questions can be answered within 45 days. Complete and total approvals are very rare. Hold strong everyone— we know the therapy WORKS and KILLS CANCER. Think about that for a min.
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