Post by
Habland on Dec 27, 2015 6:05pm
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
Comment by
DryBones on Dec 27, 2015 6:25pm
This could also be interpreted as the outstanding issues and positive data needed for approval will be given once the February meeting happens. This likely will be conditons for approval. These conditions might be very hard to meet. Really, folks, you are grasping at cob webs and falliing prey to KinkySukRocks. This aint over till the fat lady screams
Comment by
cheetio on Dec 27, 2015 7:41pm
hey...ha....after that adcomm vote the only thing they should be discussing is ..greenbacks...amounts & .drop-off point