RE:RE:RE:RE:1St quarter BTDI don't know if the FDA required them - but they did allow them. For all I know it's part of the consultation process we don't usually hear about. Theralase is new at this and may be taking full advantage of available FDA guidance before they submit the live BTD application. They need to get this right.
Legit62 wrote: The big question the Eoganacht is why did FDA require all these pre BTD apllications?? Is that standard procedure??