I haven't logged on because of the busy holiday period, but it appears that very few have.
Drug companies that apply for EAP's along side clinical trials show a tremendous amount of confidence in the efficacy of their drug, as any type of toxicity issues can derail the trial, while added success WILL be included in the NDA. The companies can apply for cost recovery, but I don't believe Insmed will. They are likely proposing the EAP to strengthen their eventual NDA filing, while familiarizing pulmonologists with the drug long before approval. I doubt they want to get caught up in the politics of the haves and the have nots when it comes to paying for the drug.
Terry kept saying that a retracement to 6.16 was in the cards.......and by golly, it looks like it could be right on, which makes me very clearly think of phrases like broken clocks being right twice a day, and blind squirrels sometimes finding nuts......
The FDA this week approved the first drug for humans based on animal efficacy studies alone. It comes from GSK (actually GSK sub Human Genome Sciences) and was trialed on only rabbits and monkeys. Of course the drug is an additional anthrax treatment, and GSK would have had a hard time getting humans to take anthrax and then try their drug. It is still ground breaking, and shows full well that the FDA is evolving.....
There are more and more drug commercials on TV, and the companies must say out loud possible side effects. For example, these are possible side effects for a psoriasis drug: It can increase your chances of having serious side effects including infections, cancer, serious allergic reactions and a rare condition called reversible posterior leukoencephalopathy syndrome.
Cancer???? So how do two out of 120 rats developing a single tumor fit in when trialing a drug for a deadly disease?? It makes me believe that the dog study is simply about warnings, but would not derail any ongoing trials. JMHO.
I took a beating on ONTY this week, as a long term trial for small cell lung cancer, involving 1500 patients, and having Merck of Germany as a partner, failed to meet it's endpoint. It reminded me that arikace has about the easiest endpoints that I have seen - also JMHO.