BioCorRx shared an update on the commercialization efforts by the company for the naltrexone implant, BICX102.
BioCorRx (OTCQB:BICX) shared an update on the commercialization efforts by the company for the naltrexone implant, BICX102.
As quoted in the press release:
The Company has formally requested a pre-IND meeting for BICX102, while also working on the IND application. The pre-IND meeting date for BICX102 has been scheduled for January 24, 2018. Scheduling a pre-IND meeting does not preclude the Company from submitting the IND application beforehand.
As outlined in the Draft Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, a response to the pre-IND meeting request is usually provided within 21 days, and the FDA aims to schedule the pre-IND meeting within 60 days of receipt of the request letter. However, with increasing workloads, many FDA divisions are increasingly unable to meet this goal, and the recently ended hiring freeze at the FDA has increased timelines.