Biomaven,
Brief question about the NDA process from a newbie:
In an ideal world, in the years of necessary preclinical tests and Phase I, II, and III testing, a drug company would acquire a pretty strong indication as to the exact nature and duration of the testing regimen that would be required by the FDA for drug approval. Given the extremely high social costs of delaying the introduction of new drugs, would it be possible for the FDA to sign off on specific test protocols BEFORE they are undertaken? Or is it simply the case that in a dynamic iterative testing environment that is designed to serve the public interest, the possibility simply cannot be ruled out that due to no fault of the company, the results for a certain patient population (in this case, patients with certain heart conditions) may simply be so inconclusive that the FDA has no other choice but to issue the nonapprovable letter?
In other words, I guess I am asking whether in your view and from a public policy perspective the system is inefficient and ought to be reformed.
According to Wall St. Jnl.: "The FDA said Sepracor's safety evaluations weren't long enough to show how [Soltara's]accumulation in tissue would affect patients, especially those with certain heartconditions."
online.wsj.com
I am also trying to get a sense of whether the nonapprovable letter is properly viewed by the investor as a blunder that could/should have been avoided, or merely a random stochastic event that delays a product introduction.
TIA,
Sam |
