InvestorsHub Logo
icon url

FORZANANO

03/23/11 3:21 PM

#48030 RE: daBoze #48025

daBoze,

I found this website that answers your request:

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.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm

icon url

Nanotoday

03/23/11 4:50 PM

#48037 RE: daBoze #48025

NNVC has not said they will complete the pre-INDA by June 30th. They have said the goal is to have filed a request for the pre-IND by end of the fiscal year.

The goal is to ask for a meeting by June 30th. When the meeting takes place will be after June 30th.