yeah, you are.
No where does it say you have to wait for the ind# prior to approval.
Might want to read the paragraph that states:
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
What the PR is stating is that the FDA has questions and thus the clinical part of it is on hold until the company can answer the questions. Not unlike HemaX. I have posted many examples of companies who get the FDA green light to start trials within 30 days. REgen did not get this.
So nice try but you still are fuzzy on the matter.
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