Optimize the Drug so you do Chemistry (Chem) and Laboratory Work.....You show that it is probably safe and that it works in models of MS. You test the Drug in Animals to show that it is safe and shows no Toxicity..... You get Ethical (E) Approval to perform studies in humans then.....You test the Drug in a few healthy people, so it's Safe for human use. Phase I Trial....then you test the Drug on MSers to see that it's Safe and maybe works. Phase II Trial. An Independent Panel, do an interim analysis (IA) to check for Safety Issues. Then You test the Drug in alot of MSers to show that it Works
(Phase III Trial. Then you get R
egulatory Approaval (from
FDA,
EMA) to Sell the Drug to MSers.
Whilst you are spending your millions, supporting the development of another drug you...