Hi @DerrickJ,Thanks mate appreciate your words. I think the...

Hi @DerrickJ,
Thanks mate appreciate your words. I think the company will definitely be looking to obtain fast track approval in ALL of its research arms... Please read this short explanatory article from the FDA which leaves little doubt that this is what the company is positioning itself for.

But what does "fast track" actually mean for NSB? There are two key fast track pathways

1. 505(b)(1) - company provides all research for IND
2. 505(b)(2) - leverage existing research in the market as well as use company research for IND

There is a detailed explanation of these two pathways here. I believe the company will need to pursue the 505(b)(1) which will be more costly but it is what it is. Note that the article states "If the FDA agrees that the Sponsor has met the statutory requirements of safety and effectiveness for a new drug (including the adequacy of the manufacturing program), then the drug will be approved for marketing.". So, for NSB this would mean at least passing a Phase 1 (Safety) and Phase 2 (Effectiveness) before being approved for "Fast Track", - so I wouldn't expect it is something confirmed in 2022. The company will be however (if it hasn't already) starting a dialogue with the FDA and will organize a pre-IND meeting, this dialogue will allow the FDA to have input into what sort of things they will want to see from the trials - "clinical endpoints", and it will allow NSB to propose their approval pathway and for the FDA to give feedback. So as these discussions progress I expect the company to update shareholders with the intended pathway for approval and the FDAs feedback on this proposed pathway.

Goodluck mate!