I will push back - there is no statement of intention, they said they WILL submit the protocol next week (now this week). Based on what they said, they have the protocol and will submit it this week. To me, how I read it, they will be submitting the protocol AT the meeting per the recommendation of the FDA.
I won't drag this out any further by commenting any further - in time we will all know whether or not they submitted the protocol at a Pre-Sub meeting so I will wait until we are told by the company what happened and when.
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