You are correct.
I believe friend
@SENARIS has - although in good faith - misinterpreted the stats. I believe I have the accurate data below. Happy to receive any corrections.
As of the end of last year, just
1.94% of actively being investigated IND's held a "Fast Track" designation from the FDA.
The FDA
Approved (ie for commercial use) a total of 50 drugs in 2021. 18 of that 50 had been granted Fast Track status. Source: See page 16 of the FDA's own report on New Drug Approvals 2021. https://www.fda.gov/media/155227/download#:~:text=CDER%20designated%2018%20of%20the,application%20on%20a%20rolling%20basis.
So yes - that is 36% - but it's only 36% of the drugs actually
approved for clinical/commercial use - out of the thousands being researched and trialled.
On pages 17 and 18 of the same report you will also see that:
- 14 out the 50 (28%) had Breakthrough Therapy designation
- 34 (68%) were designated for Priority Review
- 14 out of the 50 (28% were given Accelerated Approval.
However -
in the 2020/21 Fiscal Year the FDA received around 777 new IND drug applications! Source 1 :
https://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=cber&status=public&id=CBER-All-IND-and-IDEs-recieved-and-actions&fy=2021Source 2: https://www.biopharma-excellence.com/with-atmp-innovation-on-the-rise-sponsors-see-increase-in-fda-ind-holds/#:~:text=Data%20from%20the%20Food%20and,396%20original%20INDs%20in%202015.
How many active IND's does the FDA have on it's books? Good question. The latest count I can find is as of calendar year 2022 - and the number is 14,268 !!!! Source:
https://www.fda.gov/media/165010/download?attachmentHow many of these have been granted Fast Track over the time they have been in the system? Glad you asked. The number as of 31 Dec 2022 is: 277 (and some of them go way back to 2012)
Source:
https://www.fda.gov/media/161333/download?attachmentSo - as of the end of last year, the percentage of active INDs. (Investigational New Drugs for which documentation was submitted in the year, indicating active development) was: 277/14268 x 100 =
1.94%So IMU is
actually now very exclusive club. The FDA does not give out "Fast Track" designation easily. It's a rare honour, and a pretty good indicator that the FDA has confidence in Vaxinia.
And this is just the start. Fast Track (and Approval - including Accelerated Approval) has to be granted for specific disease applications. IMU is starting with Biliary Cancer, because it has no effective treatment and is almost always fatal.
But we also have encouraging "signals" of effectiveness in Gastric Cancer, Melanoma.... and more will come.
Also - of course - if IMU really does achieve an Accelerated Approval for Vaxinia in one cancer type (presumably Biliary to start with) - Oncologists will, for sure, start using it for "off label" use against other cancer types where patients have failed to respond to the Standard of Care and where there is growing evidence that Vaxinia gives a therapeutic benefit.
Cheers
Dave
(20min delay)
