Celsion Corporation (CLSN)

[sdtrond]

replying to both Rawnoc and Kris Kade here because I'm running low on posts for the day. :-P

KK: >>They [mgmt] indeed would be very surpised to find it's 50% more.

As would I. But as you noted, they are basing that off historical studies.
Look at http://jco.ascopubs.org/content/early/2012/12/26/JCO.2012.42.9936.abstract for a more recent example of a 95 patient RFA-only group that were up to 7cm and has around a TWENTY FIVE month median recurrence. (YES - I know it may be apples to oranges, just about ALL these stinking studies are. But it's <7cm which is a nice find since most RFA don't go beyond 5cm. And I am NOT claiming HEAT has that high a placebo.)
Mgmt is safe claiming 12, that's beyond question.

KK: >>Also I should add that a range from 12 to 18 still will meet the trial expectation. A 50% margin..a comfortable thought indeed

Ummm, yes. And at the beginning AND end of my post I noted that 18v26 would still be successful.
I THINK THAT HEAT WILL SUCCEED. I've said, blogged, and been on cc for 3 years thinking it will succeed. Just trying to make the point that 12 months is not sacred.

Rawnoc:
>>79 sites -- it's inevitable in my experience no matter how great/experienced/skilled the pool of experts, the law of large numbers inevitably has some incompetent baboons in the mix. There's going to be a few doctors or sites at least that simply suck no matter how hard you try and those sites/doctors are going to have patients with low PFS or even treatment failures.

Disagree. If you aggregate all sites that do RFA, sure. And honest mistakes happen. But to get your site hooked up as a clinical trial site you need better than baboons.

>>Those few incompetent sites will keep it under 18 months (worst case for investors) IMO.

IMO the better argument for 12ish is that treatment failures will be PFS = 0 and the RFA-only arm should fare worse for failures due to tumors > 5 cm. (assuming TDox follows dox rules and increases ablation margins while also cooling the tissues.)

Ugh, didnt want to get sucked in to the 12 month argument again.
MY POINT was that 1) DCup's model agrees with timing wrt both interim and final at 18v26 and 2) even with 18 we should be successful. You can disagree with DCups model if you wish (and I have reservations myself).

Best,
Trond