Replies to post #473 on Celsion Corporation (CLSN)

[IgnoranceIsBliss]

Trond, they have the "rolling NDA" thing going, right?

So they get the interim data, announce that it clears the efficacy hurdle, they start the rolling NDA filing, patients continue to be followed for OS....

OR, they get the data, announce it, but want to continue monitoring for PFS to support the NDA, blah blah blah....

The key thing from an investment standpoint (especially if you have Oct calls) is that they release data.

It's an odd situation. I'm not used to thinking about "one and done" trials....

Regards,
TGW

[stock_investor]

Sdtrond, Here is what is so weird to me

from magicsas interview:

"Mangrove recommends: (1) that they split the endpoints of the trial between PFS and OS and report on PFS while leaving OS blind in the event that PFS is statistically significant at the interim look...

The response that we received was that...would invalidate the SPA. "

So clsn is going to take a look at both pfs and os at interim, but not share/report on how the os looks...Yet if its trending, and if pfs looks good, then there could be an interim halt...

So imo, then they would just keep the trial going as is so they can get an os readout later on...BUT could still file there nda if pfs looks stat significant? Seems to me that there is some major confusion here....