further clinical developement doesn't say will be starting phase 2 in 2013. to me with no results given from phase 1 that the drug needs more work on the formula and experimental study may be to better understand for what indications specifically. no slam dunk here just real vague on timetable. the statement is far from saying will start phase 2 in 2013.......
Also says, "Z944 completed Phase 1 single and multiple ascending dose clinical studies in late 2012" Would you include on your annual report that you completed phase I if the results were poor and you had to redo phase I?
Why can't they just come out and say that z944 phase I was a success and it's moving to phase II with results expected by the end of the year?
Are they waiting on the FDA's direction before they release more info on phase I results?
"waiting on the FDA's direction before they release more info on phase I results"
FDA has to sign off on Phase 2 before it can be announced. Confirmation of Phase 2 will be announced with a PR. Since this is the time period Zalicus expects it to happen, that announcement can come at any time.
from the medical research counsel in th uk -- the best definitaion of "experiment medicine clinical study" I could find on short notice.
"Experimental Medicine is a broad term and refers to
“Investigation undertaken in humans, relating where appropriate to model systems, to identify mechanisms of pathophysiology or disease, or to demonstrate proof-of-concept evidence of the validity and importance of new discoveries or treatments.”
Experimental medicine precedes and informs the development of late phase clinical trials.
Experimental medicine is bidirectional. Effective translation of results from experimental medicine studies into later phase clinical research is an important outcome of experimental medicine, as is the generation of new hypotheses to be explored in the laboratory."