Biotech Values

[biotech jim]

I have now read over much of the FDA posted documents and see that the FDA is largely looking at outlier patients (appropriately) and comes to the conclusion that patients may be being overdosed. The hangover effects largely if not exclusively come from extended PK in some (obese and female) patients. The FDA is being tough here, arguably too tough. However, insomnia is a huge indication and the drug will be widely used. They do not want to see a nightmare situation (no pun intended) with sleep paralysis and hangover effects and impaired driving etc with the high dose. I wonder to what extent the agency suggested a lower dose than those used for Ph3?

I'd bet that the 20 mg dose gets approved this round.