lead article in today's biotechnology news ..., page-2

Thanks HTD.
Part of the article in Biotechnology news today:

"Prima says the funding will initially be used to kick off a Phase 2b trial for CVac, expected to begin sometime in the fourth quarter of this year.

Prima executive director Martin Rogers told BTN this morning that the company had agreed to trial protocols with the US Food and Drug Administration, but was still sorting through manufacturing issues. As the company is intending to establish both US and Australian manufacturing facilities for the two arms of the trial, it needs to develop rigorous testing protocols to assure the FDA that exactly the same product will be delivered across the entire trial.

Rogers said the Phase 2b trial had been designed so it could be enlarged into a full-blown Phase 3 pivotal trial if early results justified its expansion."

Points new to me in this are:
1. Trial likely to begin in Q4 therefore FDA approval must be soon.
2. Trial protocols 'agreed' with the FDA
3. Only trialling in 2 countries.
4. Trial design aimed at dovetailing phase 2b and 3 trials

Indicates that the FDA process is proceeding positively. Considerable potential savings on costs of trials in points 2 and 3. All positives in my view. Good luck all!