RE: 2015 Jul 2019 17:20
Marmited,
Unfortunately VAL have released so little information regarding the current trial that it doesn't make it easy for investors to draw any conclusions, we don't even know how many patients have been treated.
I wouldn't get too hung up on what you call a trial, whether it's a phase I, IIa, IIb or III, whether it's a completely fresh trial or an extension of an existing trial - it doesn't really matter. The point is that once they have finally established the optimised dosing regime, they will then need to run another proof of concept, efficacy trial with this new dose. This will most likely be a small, open label, single arm trial. Most people would call it a phase IIa.
My understanding from the wording of the RNS is that VAL will run this trial and hope that the results will attract a partner who will then obviously need to run larger, randomised trials with a view to seeking marketing approval. I'd be surprised if a partner went straight into a phase III but it's sort of academic at this stage.
I hope that helps and just to be clear, although I have spent a good deal of time researching VAL, I'm not invested.