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FDA Application for Orphan Drug Designation , PAA, MPL, page-156

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    "Having FightMND onboard and granted funding for the now successful completed (safety wise anyway) Ph1/2 trial doesn’t give you confidence of real progression with a new CEO in place and clear pathway defined?"

    It doesn't because I have already been through safety and efficacy testing for the other trials, have already been through the resolution of palatability for the other trials and with the drug being announced as palatable and safe the BoD have not made it anywhere near commercialisation. In my opinion the Elanco deal fell over because PAA did not prove the drug with a large enough number of trial participants for it to be considered successful. That was the end of the only sniff of a commercial opportunity.

    So now for some reason I am meant to believe that another safety completion and a new CEO will change. This is just my view but the pathway forward feels eerily similar to the cancer pathways we were given many years ago. I am not questioning that MnD would need a safety trial it is more we have been here before so what is really new. The only thing new is insert the MnD instead of Canine or Human Cancer.

    And @Lastly yes 7 years ago the pill was still not sorted but it has been sorted for a considerable time.


 
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