Dear Timber7,
The FDA are a powerful mob of obstructors. The impression the FDA gave the company was to simply remedy the 022 results and those results would be read in conjunction with the already filed NDA.
Now the FDA demand a refiled NDA, further delaying a result for the company.
I am disappointed with the delay by the FDA but frankly aI am not surprised. It is a delay that patience will overcome on the path to approval- hopefully!
Add to My Watchlist
What is My Watchlist?