InvestorsHub Logo
Followers 125
Posts 12252
Boards Moderated 0
Alias Born 11/08/2021

Re: biosectinvestor post# 423429

Thursday, 12/02/2021 3:03:13 PM

Thursday, December 02, 2021 3:03:13 PM

Post# of 699713
On one of your points, the 12-31-20 10k form was the last mention of a fast track approval process. Since that point they have been silent on this subject.

The time period required to obtain regulatory approval varies between countries. In the U.S., for products without “Fast Track” status, it can take up to 18 months after submission of an application for product approval to receive the FDA’s decision. Even with Fast Track status, FDA review and decision can take up to 12 months. At present, we do not have Fast Track status for our lead product, DCVax-L for GBM. We plan to apply for Fast Track status, but there can be no assurance that FDA will grant us such status for DCVax-L.




Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent NWBO News