The FDA meeting concerning the SPA-protocol is already sceduled in the upcoming weeks.
Outcome: If a SPA-protocol is negotiated there are some interesting implications of that:
SPA is a way of stopping the phase III trial before it has treated all pts. A time gainer to the market.
The second very interesting point is that a possible earlier break of the trial means that Ceplene becomes the standard of care. A performative action here.
Also, after a SPA - or no SPA - listen to the Webcast yesterday, there is a possibility of an out licening of the US market for Ceplene. We c o u l d have a path where Epicept takes Amiket, via NCI, carried to phase III. No dilution in the patents.
There will be a new front opened in the cancer war soon: Ceplene will start a trial in MDS.
Zacks is out with its report today on EpiCept (NASDAQ: EPCT), maintaining Outperform.
In its report, Zacks writes, "The Company s lead cancer candidate Ceplene has been already approved in EU and Israel for the remission maintenance of AML and a pivotal trial is planned in the US. The Company s other candidates include AmiKet for peripheral neuropathy, Azixa and Crolibulin for cancers which are all in Phase II trials. We are optimistic about EpiCept's prospect. Current valuation is low and we see a great potential for appreciation in share price as the Company continues to advance its pipeline and boosts its balance sheet."
Zacks has a $2.50 PT on EPCT.
At the time of posting, shares of EPCT were trading at $0.44.