An ultimate NDA would be based on the outcome of the *third* phase-3 trial, which is not yet underway. Hence, a potential NDA for Milnacipran in fibromyalgia appears to be a 2008-09 event at the earliest.
I give that about a 50/50 chance of being true:
a) They have always planned for a third milnacipran trial albeit for a 'different indication'. I suspect that the new trial will be for a different cohort (e.g. admit depressed patients since it appears that the original reason for excluding them from the first 2 trials was mistaken)
b) If the second trial is p=0.01 and clean it seems unlikely that the FDA would reject an NDA of that trial supported by the just finished trial which just ***barely*** missed.
I’m actually surprised that FRX is committing more money to this program. If the decision were up to me, I wouldn’t do it.
Very stand up of you to admit the surprise. But some comments:
a) It is not clear from the PR that FRX is continuing the same payment scheme (where FRX pays the vast bulk of the trial costs).
b) I strongly suspect that FRX's plan is for significant quantities of off label use in chronic pain indications since it will be (I believe) one of the first FDA approvals for nueropathic type pain.
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