Replies to post #333606 on Innovation Pharmaceuticals Inc (IPIX)

[sunspotter]

"Yes, the FDA can get back to the company earlier than the 30 days."

Of course they can, exactly as you say.

The reason that people are tying themselves up here is that some are confusing a Complete Response Letter (CRL) with a response.

A CRL is defined as a negative response to an NDA submission:

"Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in § 314.125 or § 314.127, respectively."

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110

A CRL will list the deficiencies in an NDA or ANDA.

FDA can of course approve an IND application before 30 days as several posts including yours make clear:

" on earlier notification by FDA that the clinical investigations in the IND may begin."

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview

And in normal English that would constitute a response, so contrary to what has been posted on this MB it's quite legitimate to hope that IPIX do get a response from FDA before 30 days are up. Especially if that response is positive.

Also if they don't respond at all within 30 days then IPIX can assume the IND is approved.