Yeah, I’m not certain I come away with the same conclusion. Before when I asked if any MAA acceptance would be promptly reported, he responded, it’s a “milestone”. Which I took as a yes. Now I’m wondering if he is using the singular and plural word “engagement(s)” and the multiple use of word “approval” to say the they are not going to report any regulatory interaction until an “approval” decision is made or denied.
Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.
We did not speak about the PIP engagement with the MHRA, but we did let everyone know when our protocol for 2 pediatric trials were approved (as an example)