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Spideyboy

04/03/18 9:02 AM

#11638 RE: jp7204 #11636

End of the year at the earliest.

We don't know for sure yet how the development is going. The February presentation stated ARS pivotal to begin in 2018. If they have already started it then perhaps by end of year. But I would expect even if the results are completed by end of the year, I would say that even with the new power of the FDA and agreement with the military to bring products through faster, that it will still take a couple of months at least to have gone through all the data and to getting the final approvals.

Once given the all clear on the legal and ethical sides, given the short time for 'recruitment' and the short duration for each NHP of about 45 days from irradiation, but probably being a tiered dosing approach, my hoped for timeline would be by 1Q 2019 for approval.

To have a better idea we really need to see an update from the company, (probably would be in an updated corporate presentation), whether or not they have actually begun the study. It does appear from the February presentation that they have the funding. Again will also be nice to see something specifying the funding acquisition for both the prophylactic as well as mitigation study.