More targeted Phase 3 trial will show strong results
What's funny is how so much is riding on meeting the primary endpoint, when one really has to understand medicine today and where clinical trials are going. The goal of any drug is to give the right drug to the right patient, and the increasing focus on clinical protocol today, as the FDA supports, is more targeted patient populations. Now, ONTX's management has a VERY CLEAR patient population for Rigosertib...the ad-hoc, post analysis sub-population. Those are the patients which showed a statistically significant doubling of life expectancy, which is highly meaningful. This sub-population was a large portion of the trial, which is meaningful too. Going forward, I am highly confident that management will work with the FDA to develop a Phase 3 trial to target this sub-population in a multi-center, placebo control trial. And, the results, should be powerful. Expect a trial to start in early 2015, as the remainder of the year is spent analyzing this data, meeting with the FDA to set up the Phase 3 protocol and then enrolling patients.
Ultimately,Rigosertib will double the lives of those patients who should be receiving the drug in the first place...and that is everyone's goal.
This is just phase 3. The steps after this include FDA's review meeting and the new drug application (NDA). Take the recent case of Chelsea's (CHTP) Northera, it took them nearly 21/2 years after their first NDA to get approval. I wish Onconova the very best.,