InvestorsHub Logo
icon url

Peter Penny

05/19/21 11:14 AM

#4026 RE: ITSON04 #4025

Hm
icon url

powerbattles

05/19/21 11:30 AM

#4039 RE: ITSON04 #4025

Sec. 312.130 The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.




icon url

powerbattles

05/19/21 11:40 AM

#4050 RE: ITSON04 #4025

This isn't IND trials! Its IND application Pre-Investigational New Drug containing confidential an investigational. New drug application for a new drug will be handled in accordance with the provision for the confidentiality of data and information in applications submitted in part 314.