RE: Manufacturing / Scalability - US Criteria3 Nov 2021 11:24
AndyB4, you raise an interesting point when you say "The ACTIV2 trial is only important now if SPRINTER messes up. But in that case everyone will pull their money out anyhow." I say interesting, because I think you are right, some PI's and maybe an II or 2 will plan to walk away if as you say Sprinter "messes up". However, I do also think ACTIV2P3 is very, very important - the general US respiratory market has un-met needs which will outlast Covid. I do believe some big smart money is on Synairgen's as a longer -term play here. When you read through the US documentation coming out, such as the link I gave earlier, it is evident how costly, rigorous and painstaking a process this has been for all involved. Will the US stop Synairgen's participation in ACTIV if Sprinter yields sub results? I very much doubt it. Could the ACTIV2P3 trial produce different results to Sprinter - yes anything is possible IMO, different trial, different set-up, population, protocol, criteria, oversight, etc etc. There are many reasons that potentially efficacious drugs can fail to demonstrate, for example, to show efficacy, including a flawed study design, an inappropriate statistical endpoint, or having an underpowered clinical trial. I'm not saying any of this applies to our trials but just giving examples. The point being that some things can be remedied and subsequently produce different results. As a few holders here have previously stated, personally I would use the opportunity of a lower SP to invest further (if Sprinter failed and assuming no other red light than sub results and depending on the nitty gritty of data we get). For me the significance of a successful A2P3 is underrated and worth sticking with, I see it as the final piece of the pie with cream on top. But I also get that this is a strategy that is not attractive to everyone. It's been a long haul after all. It will suit some to cut and run. I would just say there is life after Sprinter, don't rule out what might lie ahead and look at all options when the time comes.