Marker Therapeutics Inc (MRKR)

[Rkmatters]

An orphan drug candidate is all a designation is, yes. It needs approval eventually otherwise the designation will become meaningless. In the Orphan space it sometimes is a race. The product that gets approved first wins 7 exclusivity, and anything behind would then need to test along with that new standard of care often to show an improvement in survival. In this FRa space, it is quite possible a mAB drug like Herceptin will be approved first, and then TPIV would need to test their phase III along with it to get the biological Orphan status position. And it would need to show efficacy above and beyond what the Herceptin-like drug can do on it own. In my view, it will do that as the synergies have already been seen with Herceptin mAB. Anyway, this is a few phases away. For all we know TPIV could become approved based on strong significance in a large Phase II trial, which the DoD trial is.

By the way, this marketing exclusivity that Orphans gives is why it is good to have products outside of the Orphan space too, to which they have with their HER2.