"A for effort, but that’s not how it works.
Has the IND been submitted?
“Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials.”
If the company DOESN’T hear from the FDA within 30 days, it can start the planned trial."
That's not the whole story either.
Per Title 21: Food and Drugs
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart C—Administrative Actions
Contents
§312.40 General requirements for use of an investigational new drug in a clinical investigation.
(b) An IND goes into effect:
(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under §312.42; or
(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.
(c) A sponsor may ship an investigational new drug to investigators named in the IND:
(1) Thirty days after FDA receives the IND; or
(2) On earlier FDA authorization to ship the drug.
(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.
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