From some time ago, Micheal explained the diagnosing of ALS in the USA is a bit slower than Australia, from memory, due to the difference in health systems. That means by the time that many folks are confirmed as having ALS, the more advanced their situation. So I can understand why they (Healey) want to further limit the entry to improve the chance to observe how well or not any trialing drug works, particularly when the disease is so fast moving in many patients. This means the pool of potential trial candidates is conceptually smaller. That said, the active trial recruiting (Healey and other non-Healey) has been low for quite a while and that means there will be a load of people willing to join the regimens on Healey as soon as recruitment commences. I expect it will still take a bit of time to fill all the seats as more drugs also concurrently recruit.
That said, they have around 76 sites and so we need very few from each site to fill our on drug and placebo quota. Some locations will have only a small pool of patients while others will have quite significantly more. Time will tell but the ALS community and Healey are highly motivated so I think we are in good hands. It looks like we (NUZ-001/regimen H) is first cab off the rank and that would logically benefit our speed to recruit. Just not sure if they will preference other regimens (I, J, K) for recruiting once they come online.
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