Celsion Corporation (CLSN)

[sdtrond]

Rolling NDA means they can submit the various components of the NDA (preclinical, CMC, clinical) separately, and some of it early. Normally the whole shebang has to be filed as one piece, but Fast Track allows piecing it out.

So really, whether or not the interim is successful or simply continues the trial, they will file the NDA on a rolling basis.

The Fast Track means the PDUFA date is six months from filing. Note that, 1) the FDA doesn't get penalized if they are late and 2) even if interim is overwhelmingly successful, it will take them about 4-8 months to put the whole NDA together and file. So best case is if we find success at interim in Oct, we'd file by March or so, and get a PDUFA date of approx Sept 2012. And that timeline is so fast I would put it at less than 5% of happening if interim is great.