Member Info for Grailor

Hi Jersey, no that's not quite it. What they are saying is that the additional endpoint analysed by NIAID has the 'potential' to be used as the primary endpoint in any future pivotal Phase 3 study. What this does imply is that, given the word 'potential', they have not yet got buy in from FDA that they will accept this as the 'primary endpoint' for the pivotal registration Phase 3 studies. When and if they do get FDA endorsement for this endpoint it would be good for HVO to release that information as it would then indicate that they have agreed a path to registration with FDA. This would make the situation much clearer for any potential partner/acquirer wrt what to do next.
Re-optimum time to do a deal and relative value - well the closer you get to regulatory submission and approval and therefore the market, the greater the value of the asset. The reason being, of course, is that the risk of failure reduces as you progress through the drug development process. The flip is that the further along you get in the development process the more expensive it gets to undertake that stage of development i.e as per previous post, HVO would need of the order of $50-100M to get to regulatory submission IMO. Hope this helps.

Jolanta, I have worked in the Pharm industry for 30+ years in very senior positions, so at least my opinion is informed.
Jersey, I absolutely agree, HVO is not able to progress this to market on its own. As I said previously, the next inflection point for HVO is when they announce a potential acquisition or co-development deal with a major pharma. They do need to get on with it though as any delays to the development of this asset start to erode its value.

Hi tryto. To take this to market from where we are at the mo would cost approx $75-100M IMO.

Hi Jersey, we would certainly benefit from a bidding war, fingers crossed. Re the NDA/publication - any potential acquirer will make a deep dive into the data from the Ph2b and previous studies, pre-clinical data, manufacturing data etc etc and this is all done under NDA. The company can have several potential acquirers under NDA at any one time. When they have completed due diligence then the bidding can start! The publication does act as ratification of the validity of the results when published in a peer reviewed journal - so still a good thing.
ATB

Jersey, I agree with what you are saying other than the part around the publication being the advertising hording. Any big pharma company will have been all over the HVO data under an NDA for months now, they don't need to see the publication. I had hoped that HVO would have been able to announce a licencing deal, acquisition or strategic partnership during the JPM conference in SF last week but.... - lets hope that they have at least got ongoing discussions.

IMO the next real 'spike' will occur when a potential acquirer is announced and/or HVO announce commencement of the Ph3 program. We have been sat on positive Ph2b data for months now, the Ph3 program should be agreed with FDA and the company announcing that they are ready to get going.BTW I have been holding here since April 2017.

Maybe an announcement will be made at JPM next week, to ensure max impact???