Completely disagree that TMDI needs to be FDA approved.
So when MDT and TMDI realize human trials are a success why would they wait for the whole FDA process to get this over with? No reason to delay. MDT knows the FDA and it's process like the back of its hand. They will KNOW WHAT THEY HAVE and with human trials a success (yes an assumption at this point) the majority of RISK IS OFF THE TABLE. Of course it's speculation but this seems way more realistic then waiting for FDA approval. Either way we aren't going to see human trials for at least a year so we have time to speculate ourselves to death:)