no i think they know what the FDA wants, from their perspective...but before submitting it it makes sense to double check that is correct. Its a good thing they are able to have this chat with FDA as it could save further issue if they had interpreted the request incorrectly.
But its a double edged sword. They had better get it right this time as there is no good excuse not to.
But if you recollect they had in depth discussions many moons ago around what the FDA wanted to see in a trial submission...and still we hit this hurdle. So its no certainty but its worth double checking if they can.
I suspect from MTs language around announcing developments in this space, we will be waiting a while unfortunately. Imo only.
Is there a cut-off point where we miss our window to commence the healey trial and then need to wait until the next window?
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