GTC Biotherapeutics (fka GTCB)

[DewDiligence]

When will GTC receive milestone payments from Leo?

Referring to #msg-12430822, we know that there are $38M in clinical/regulatory milestones for the ATryn DIC program. The only milestone event that GTC has explicitly disclosed is the completion of the phase-2 trial by Leo in DIC.

However, I think it’s reasonable to assume that the GTC-Leo contact includes the standard kinds of milestone-triggering events employed throughout the drug/biotech industry.

I would guess that there will be a milestone payment upon:

--Completing phase-3.
--Acceptance by the EMEA for review of Leo’s MAA for the DIC indication.
--A positive opinion by the CHMP in support of approval for marketing (probably the largest milestone in this set).
--Formal clearance for marketing by the EU Commission.

There may also be smaller milestones for regulatory approval in Canada and the Middle East, which are territories covered by the Leo partnership.