Quote:
Originally Posted by aftermathman
The main hinderance to Prosavin is the lack of a suitable partner to provide Oxford Biomedica with the finance to take it to market.
I am unclear as to the Safety requirements from the various regulatory bodies, Prosavin appears to have safety data going back 9 years, do they need this for all stages of the test data ? If so, how does anything get to market ? There is a new "super Prosavin" in the wings that will need to be tested, lets hope this is on a faster timescale than what has come before.
I have heard about 2-3 years ago a phase III planned for this year but I can see no clear plan.
I will contact Oxford Biomendica and attempt to get the schedule.
Neil.
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Although a company will always monitor side effects throughout the 3 phases to drug approval and even phase 4 post approval they will not be required to conduct another safety trial.
Why do you think they can't find a suitable partner? They currently have partnerships with Novartis, Pfizer, Sonofi, Biogen, GlaxoSmithKline and about a half dozen other companies, all with deep pockets. So they obviously have the contacts and relationships. Why should they have problems with Prosavin?
Gary