Now we can understand why Epicept wanted a mutually approved minutes from the FDA meeting in December on the design of phase III study of Amiket:
Firstly, the minutes/FDA offered Epicept to make one (1) study before approving the NDA. It shortens the process and make it less expensive, of course.
Secondly, the sensational, which took me by total surprise:
"An Additional two-arm efficacy study in another Painful Peripheral Neuropathy May Be Performed as an alternative strategy to a second factorial-designed trial for the NDA filing, Which Could Potentially Lead to a broad label in the treatment of peripheral neuropathic pain."
The confirmatory follow-up study,
+ will be two armed, Amiket versus placebo for 12 weeks!
+ And , the sensational part, the trial may, according to the protocol, target the broad 15 million patients diagnosis if it chooses to go for that target!
I guess we will upda have updates from several of the financial actors on this turn-around development.