Today's news that the Company will not need to conduct an additional confirming Phase III study has been adopted by some of us, but not all.
Now there's an EMA decision on this.
The decision has, at least, two points:
1. Ceplene is more and more rooted in the scientific community. It will give a sales impact. The fact that there is just need to perform one study is dependent on s t r o n g results in the single studie we already have had. Now the Swedish guidelines will be reformulated on Ceplene use. Other countries guidlelines can roll out. I presume everyone sees the importance of this.
2. One of the queries in the FDA application has been this very issue. In its decision, the EMA gives a contribution to the FDA application EpiCept will submit very soon. To good to be true? :-) Some timing here! Epicept do have a momentum now in the European scientific society. There are many people acting now to spread the message. Guess that we will see some of that energy moving to the market as one day closes for another.
There will also be an impact on later trials in other diagnosis starting this year aswell as for the applications on the China and India markets.
After this news it is now a low treashold to prescribe Ceplene for doctors. For the broad investor society, not following details, this is a safty declaration.
What a terrible shame - most PR by the company is a big "yawn". This is indeed reassuring, but doesn't feed either the company or the shareholders.... Once again 6 months too late, just like the original projections for FDA NDA application (originally end 2009, now June 2010), Ceplene deal (6-9 months too late), NP-1 deal (again running slowly....)
It will be easier for Ceplene to get into the guidelines in each country in the EU?
That this will promote sales?
That the treshold for the doctors to use a new treatment is lowered?
The FDA-application is the precious thing in this CO. A 10$ game. Everything that a t h i r d p a r t y do that makes having an approval more plausible for the application is a big step forward.
This is excellent. The message is not from just anyone, it is from the same authority in the EU as is the FDA in the US, saying: Epicept is right about the need of just one pivotal study for Ceplene. (Their argument is very good, there will be an ethical problem recruiting patients to an alternative (arm of the study)that my lead to death, when there are an excisting therapy out there.)