Via Twitter, @PtwitB asks, "Adam, what's your opinion on Sequenom ( SQNM)?" I believe strongly FDA will not permit Sequenom to market a non-invasive, blood-based gene test for Down's syndrome without a full agency review as a medical device. That's counter to the current guidance given by Sequenom, which is planning to launch the Down's test in the fourth quarter of 2011 as a laboratory-developed test.
My column on MELA Sciences ( MELA) and the statistical dust-up over its skin cancer-detection device MelaFind generated a good amount of reader reaction, both emails and comments posted to the bottom of the column. Sam H. emails to ask where I stand on MELAFind's chances for approval. "Adam, regarding your latest article on MELA: Given your historical experience on these matters, where does that pull you to weigh in on this matter?" I don't believe FDA will approve MELAFind based on the currently available clinical data. My bearishness extends to the outcome of the FDA's advisory panel on Nov. 18, although I concede that panel votes can be a bit of a wild card. The fact that FDA issued a "not approvable" letter on MELAFind last March, however, speaks loudest.
@aeroforce tweets, "Adam, what are your views on final 510(k) approval for Cardium Therapeutics' ( CXM) diabetic
Nick H. asks, "Adam, what are you hearing on Biodel's ( BIOD) fast-acting insulin product? Can it overcome the India data points or will it have to go back to the table for some more data analysis?" Let's see what the crowd thinks. According to the early entries to my FDA Drug Approval Contest, a significant majority of people believes FDA will issue a complete response letter to Biodel, meaning no approval for Linjeta on Oct. 30. I'm in that group, too. Why the pessimism? The India issue is a risk. The phase III study of Linjeta in Type 1 diabetes patients failed to meet the necessary non-inferiority test compared to Eli Lilly's ( LLY) Humulin. Biodel blamed the disappointing results on mishandling of blood samples in India. When Indian patients were taken out of the analysis, the Linjeta study was positive. That's an entirely plausible explanation, but will the FDA go along without requiring additional clinical data?