Replies to post #375083 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Exactly right.

[snoopycomic]

Only if you are a BP, small Biotherapeutics like ours have a very uphill task as BP has corrupted FDA

[improving]

Fox, couldn't agree more.
Numerous avenues exist for expedited FDA drug and biologic approval:

Fast track designation in the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. No. 105-115).
Exists for new therapies that, alone or in combination, addressing unmet medical needs for a serious condition, sponsor can request fast track designation 21 U.S.C. § 356(b).

Regenerative Medicine Advanced Therapy Designation
under the 21st Century Cures Act in Section 3033. Applicable to regenerative medicine therapies, i.e cell therapies, and therapeutic tissue engineering products, human cell products and tissue products, including combination therapies.

Breakthrough Therapy Designation
Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) to decrease the time for drug development and review (Pub. L. No. 112-144). For new therapies, or combination therapies, demonstrating substantial improvement over existing therapies in at least one clinically significant endpoint (21 U.S.C. § 356(a)). Designation allows for expedited reviews and additional assistance from FDA.

Accelerated Approval
Accelerated approval under the original PDUFA (Pub. L. No. 102-571).
Allowing for expedited approval based upon surrogate or intermediate endpoints.

Supplemental BLA's
Additionally, approved BLA's may be supplemented for additional uses or indications (solid tumors), and may shorten the time of the FDA's review. 21 C.F.R. § 314.150.

So, looks very good to me that there are a number of expedited review avenues open to NWBO. Best