Biotech Values

[rogerm]

MIN-101's P2 was sig stat with both the 32 &64mg doses. Was also sig stat on many other tests. Good safety data except the 64mg arm had a QTc issue. That appears to have been solved with a delayed gastro release formulation. No FDA approved drug yet for neg schizo in US. Pharma not willing to test their drug in difficult Schizo Neg Symptoms indication vs placebo. Allergan tried sNDA for Vraylar because it beat a Risperdal arm for a neg symptoms. But the FDA refused because it wants to see a drug tested in a moderate positive schizo pop with high neg sym tested against a placebo arm which is what NERV did with its P2. NERV will have 101 P3 results in 4Q19. ACAD's pima is similar to 101 in that both are selective for the 5HT2A receptor. Pima just failed its P3 but drug was used as adj therapy for schizo & it was not a focused neg symptoms pop. But it should be noted pima was still able to get sig stat on a 2nd endpoint that just happens to be 101's P3 PE.