Ann: Paradigm delivers IND to US FDA for Pivotal OA Program, page-29

From FDA website we may not need to wait for a response just go ahead with trials after 30 days.

Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.

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.

Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.