FDA Teleconference Dec 10th
The review issues discussed were related to Chemistry, Manufacturing and Control issues (CMC) and Telestas manufacturing facility. As part of the meeting, the FDA briefly discussed the recent Advisory Committee and provided answers to several questions posed by the sponsor. If the FDA were going to reject MCNA why would they be discussing all these things. They want to make sure everything is in place before approval. They only briefly discussed the ADCOM this tells me there was not much weight to the outcome (Vote). This release by Telesta was very well orchestrated and thought out. A lot was said in this one paragraph. If everything is in place in Montreal we will get early approval and this I believe is what the institutions think too. Happy New Year Folks Ps eternally optimistic