Drug Development from Inception to Commercialization
Biotech companies can be highly profitable for investors that get in at an early stage.
Drug Development from Inception to Commercialization
The typical timeline for a drug approval from the initial discovery phase all the way to commercialization is 10 to 12 years. It includes the following:
Patent application:
Patents for Canada, the USA and EU approved in 2018/2019.
Basic research and proof of concept: Complete.
Pre-IND meeting and IND approval: Complete.
Toxicology and Animal testing: Complete.
Phase 1 trials: Complete.
Phase 2 Health Canada meeting: Complete.
Phase 2 small cohort trials: Ongoing.
Phase 3 large cohort trials:
NDA meeting:
Health Canada filing/approval:
Submit technical data package:
Phase 4 Post-marketing studies:
Market Launch:
We are in phase 2 clinical trials, which typically takes 6 to 8 years. With proper financing we can complete the remaining tasks in the expected timeline. And because our target indication (C Difficile infection) is considered an “Unmet Medical Need”, it is expected fast track status will be applied by regulators.
A possible exit strategy is after successful completion of phase 2 trials (now ongoing), when larger Pharmaceutical companies can come on board with further financing or complete buyout. Typically the company valuation increases with successful completion of each task.
-
LIVE
Right Side Broadcasting Network
2 days agoLIVE REPLAY: President Trump Hosts a Town Hall in Fayetteville, NC - 10/4/24
4,918 watching -
1:23:19
Glenn Greenwald
6 hours agoProfessor Jeffrey Sachs on Ukraine, Russia, Israel and 2024 | SYSTEM UPDATE #347
74.6K186 -
4:47:10
Nerdrotic
9 hours agoJoker 2 is Pointless, TOXIC Fandom Strikes Again! Rings of Power - Friday Night Tights 322 w/ Fringy
108K66 -
1:38:49
The Pascal Show
5 hours agoBREAKING! Tupac's Family Investigating Diddy For His M*rder
56.5K11 -
47:26
TheTapeLibrary
18 hours agoNight Drive Paranormal - 5 Terrifying but TRUE Paranormal Stories
12.7K -
1:18:49
Man in America
8 hours agoCloud Seeding, Weather Control & Cancer: The SHOCKING Link REVEALED w/ Jonathan Otto
22.1K12 -
1:13:04
Flyover Conservatives
23 hours agoDon’t Miss This! Hollywood Legend & Emmy Award Winner talks Conservatism, Reagan’s Legacy, Abortion and the 2024 Election – Robert Davi | FOC Show
22.2K4 -
54:34
LFA TV
18 hours agoRegime Media Celebrate Springsteen as Americans Drown | Trumpet Daily 10.4.24 9PM EST
18.1K6 -
3:54
In The Litter Box w/ Jewels & Catturd
11 hours agoSaturday Night Gone Wrong - Crooked Creek
56.2K97 -
10:05
Adam Does Movies
8 hours agoJoker: Folie à Deux (Joker 2) Movie Review
49.6K16