Interesting, particulary the comment about no Australian company ever getting BTD. Since BTD includes extra assistance from the FDA, could that imply he sees a bias by the FDAagainst foreign companies seeking BTD (particularly considering the FDA is taxpayer funded)?
He was also honest about the fact that they did change the scope of the trial, from purely safety to include measuring improvements. This was probably enough for the FDA to not tick a couple of boxes. It gave them an excuse.
Thanks for posting this reply. You didn't need to take the time to share, yet you did. And I for one feel a lot more comfortable continuing to hold because you did.
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