It's a regular 6 month trial. Where is "quick study" coming from? Is that Sunil's sugar coated spin?
They will still have to recruit patients, They still have to conduct the trial, they will still have to analyze the data, they will still have to refile the NDA. Does that sound imminent to you?
I don't know if they were able to show them data that the plasma levels of 4 implants is equivalent to 8mg of Suboxone, but, if they were able to do that, then the idea is that they run one more trial and the results should be just as good as the first two trials.
From there, it would make zero sense for the FDA to deny approval, but it already made zero sense for them to do it the first time around, so who knows for sure.
i think nowak what didn't sit well with the fda is that titan used a supplement drug, what they should have done was have the results using probuphine alone if that didn't work with the entire population they should adjust the dna for only that population. My only question is did the fda agreed with the trial design (using the combination) or titan just did it on their own. As per sunil they were always working close with the fda, they had 2 PIII trials....why didn't the fda tell them that this is not what they want? 3 years ago... like you said it makes no sense.