Thanks for your response.
Well, there's nothing untoward about the share price decline since November, that's happening all over the place in Health stocks. After a great run most have been sold off. Those that haven't cashed up are getting belted for the CR they haven't even announced. At least that's not a problem here.
You know much more about IXC than I do. From what I know, you have plenty of cash. Your CEO and founder has skin in the game and experience. You have a cornerstone investor who's no idiot but not unfortunately noted for this type of investment. The University of Brimingham and Prof Sinclair are still with you.
Downside is the market has lost confidence in the timeline and figures there's plenty of time to buy up when the trial is underway. Plus sentiment on Bio is terrible.
SH are right to be frustrated with the SP performance I get bent out of shape when mine go down too but it is delusional. The market doesn't know diddly about the drug and it's efficacy and it's not like the threads are filled with neurologists with alternative solutions. It's just frustration. (Easy to say when you don't hold, I know). Over on the CUV thread they're bemoaning shorters but clearly they have anxiety about growth and execution risk.
I need to go back and research the separation of the FDA and EU trials to better understand what that means but presumably the outcome will be binary whether in the US or Europe. Either exenatide can significantly reduce ICP in IIH patients or not. If it does, you'll be off to the races. If not, there's no consolation prize.
According to the half yearly In November, Invex announced the finalisation of its regulatory and clinical trial strategy for Presendin™ in IIH.
The completion of this strategy was an important milestone for the Company after significant scientific and regulatory consultation. The single Phase III clinical trial has been
designed to meet the requirements for market approval of Presendin™ for the treatment of IIH in the EU, UK and Australia (IIH EVOLVE). The trial plans to enrol 240 newly diagnosed IIH patients who will be randomised to receive either once weekly subcutaneous injections of Presendin™or placebo across 37 centres in Europe, UK, Australia and the United States (US).
Outcomes from the IIH EVOLVE clinical trial are expected to facilitate future discussions with the US Food and Drug Administration (FDA) regarding registration of Presendin™ in the US in the future.
Also Invex successfully filed the first Clinical Trial Application to commence the IIH-EVOLVE trial in Australia, through an application to a specific Human Research Ethics Committee (HREC).
So more work for me but I have seen mush worse than this but timing is of the essence. Do you know when the trial is supposed to start (save me a few announcements
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(20min delay)