Ann: Appendix 4C & Quarterly Update, page-11

"................I'm stunned the Options are holding ground @12c ................."

I'm not sure which options you are referring to NZT? Or are you looking at some old pricing?



Regarding the tablets. I'm pretty sure that they are be 100MG tablets as the dose is 10mg/ KG of body weight. It's still possible they could run out I suppose, but I'm thinking that the FDA may impose a lower dose of 6mg/ Kg of body weight (at least to start) so the tablets will last a bit longer at a lower dose. If this were to be forced on us by the FDA, even at the lower dose the results of NUZ-001 in the phase 1 trial were still far better than standard of care and once the FDA see that the safety of the phase 1 and OLE study is being repeated surely they would then okay the 10mg/KG dose? By this time however I would expect that we would have been bought out as we would have the IND (although at a lower dose), a progressing phase 2/3 showing better than standard of care in survival, QoL and reduced progression and hopefully new preclinical results which show a likely positive impact on other NDDs .

I find it very strange that the FDA are holding us up on "safety" concerns. They have the Healey team eager to start the trial who will be watching for any safety issues through a magnifying glass. Wasn't the whole point of the Healey program to be a trusted organization that would work hand in hand with the FDA to safely fast track new treatments for ALS? It's been a year since any new trials started on with Healey. That's half a lifetime to someone fighting the ALS beast on the current standard of care. MT has contacted the FDA asking if NUZ can help with any concerns, the Healey team are happy t progress the trial and talk to the FDA on NUZ's behalf but all to no avail.