Halozyme Therapeutics Inc (HALO)

[Skeetz99]

FDA Clinical Hold on PEG20 - Please Read!

Will the FDA really respond in 30 days?
Posted by BO ( ymb ).

Will the FDA really respond in 30 days?
There seems to be a little confusion about this. Whitten, on the last conference call, and at the Wedbush conference said that the FDA "indicated" that they would respond to Insmed's response within 30 days after receipt.

IMO, indicated may not be the appropriate word. According to the Code of Federal Regulations, Title 21, section 312.42, the FDA is obligated to respond within 30 days.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.42

FDA shall respond in writing to the sponsor within 30-calendar days of receipt of the request and the complete response. FDA's response will either remove or maintain the clinical hold, and will state the reasons for such determination. Notwithstanding the 30-calendar day response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted.