FDA and M/M - do we have a link? (just for refere
Post# of 148155
Actually you can sort of see their logic at this point - they would want to reduce the risk exposure to those that need it the most. ie. if a drug had side effects that were unknown due to lack of testing, you would want to reduce the chance of exposing a large population to those side effects. For S/C - the population is smaller and the risk / reward decision is easier to make.
What would be need is probably a few thousand cases with no reported (or well known) side effects to be considered.