Patrick writes, "I wanted to get your thoughts on Anadys Pharmaceuticals ( ANDS) and the FDA approval for them to go ahead with phase II trials. Seems to me that with the FDA allowing them to move forward, the rash issue with phase I is not as significant as it may have appeared." What's with hepatitis C drugs and rash? Weird. Anyway, yes, I agree with Patrick that the FDA's sign-off on the next phase II study of Anadys' hepatitis C drug ANA598 was a positive sign, although I think the rash problem that cropped up in an earlier trial will remain an overhang until we get more data from this new trial.
Next up, an email from Joe C.: "Why not write more about Alzheimer's drugs in development given the huge rewards that are potentially there? Nothing else comes close to the huge potential." 2010 will be a huge year for Alzheimer's research, so there will be much to be said and written later on Medivation ( MDVN), Pfizer ( PFE - Get Report) and Elan ( ELN) -- all of which have Alzheimer's drugs in phase III clinical trials with results expected next year.
Terrence B. writes, "You said you were positive on Allos Therapeutics ( ALTH) going into the Sept. 1 panel meeting, but the company only has phase II data. Doesn't this make approval unlikely?" Seeking approval solely on phase II data is usually foolish except when the FDA says it's OK, which is what the agency told Allos. The phase II study of Allos' cancer drug pralatrexate, dubbed "PROPEL," was conducted under a Special Protocol Assessment (SPA) with the FDA. An SPA is essentially an agreement between a drug company and the FDA stating that a clinical trial's design, including the size of the trial, the clinical endpoints used and the data analysis plan, are strong enough to form the basis of a drug's approval. An SPA in no way guarantees a drug approval, however. In this case, the response rate, duration of response and safety profile of pralatrexate needed for approval were not set by the SPA covering the PROPEL trial. All those things are subject to FDA review and will be discussed at the Sept. 1 advisory panel meeting. I happen to think the pralatrexate efficacy data, as we've seen it, is strong enough for approval.
Finally, an email from Dan M. "I wanted to get your current thoughts on AMAG Pharmaceuticals ( AMAG - Get Report). The stock seems to be getting pummeled lately. I just don't get it. It seems they are going to have to either announce a Davita ( DVA) partnership or provide some positive