Denuzio, nothing has changed that I am aware of. Others were making mention of the demonstration, so I was just curious if it was actually a reality, or just a possibility. The fact that Dean said he would like to, or he would try, leads me to believe it isn't going to happen. Just another empty statement about producing some images. We all know what would happen to the SP if that were to happen, with or without FDA approval at this time. A shred of evidence that the thing works would go a long way, but after all this time and failure, logic says that proof just doesn't exist, except on paper.
This can't go on for much longer, unless the dilution process works, and Dean is able to just keep stringing this along. The idea of no real time line for the "3 phase" re-submission is as frustrating as it gets. This "new protocol" plan coming out of the blue was surprising as well. I can't believe that there isn't anyone that has been able to verify what MWE's involvement has been or currently is at this time. For whatever reason, if it was confirmed they are truly playing a big part moving forward, I would have a trace of optomism, but nobody seems to be able to prove either way if they are even "consulting" on this, much less putting significant talent and time towards getting it through.
I agree with a previous poster, simplified to the fullest. The FDA spelled out what they wanted, and Dean didn't produce it. They have spelled it out again, so comply and give them what they expect. I don't recall reading in the NSE letter anything about a 3-phase review and multiple meetings, which leads me to believe Dean can't give them what they want, and wants to create a way to beat the system. No facts from me, just preception, which is 99% of this board. Confirmation that MWE is even involved right now would be a bonus for me right now.
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