Replies to post #586 on Celsion Corporation (CLSN)

[IgnoranceIsBliss]

there is NO reason the DMC advised asking to amend SPA

Trond:

Again, don't misinterpret my posts.... I'm long here like you and am hoping for the best.

The press release did not say that the DMC recommended anything but a continue. Here's the actual quote from Tardugno:

"The DMC's unanimous recommendation is a significant achievement for Celsion based on the most comprehensive review of the HEAT Study to date, including the first-ever review of efficacy results," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Critically, we have the potential to realize a successful outcome to the study prior to its planned completion. We are encouraged by what may be sufficient rationale for conducting an additional preplanned efficacy review prior to the 380 events called for in our protocol, and will seek to amend our Special Protocol Assessment Agreement with the FDA accordingly. We thank the DMC for their work and thorough review, and are grateful for the continued support and enthusiasm from the healthcare community, regulators, our investors and our employees."

Regarding the "sufficient rationale" -- it is possible that the DMC suggested this, but if so, Tardugno is modestly undermining their independence, because then he would be insinuating information he's not supposed to share. It is more likely, in my opinion, that the "sufficient rationale" is Celsion management's rationale, which could be based on the same kind of modeling we've done, or other information we don't have, or simply the decision to tell us that we always had the ability to go back to Kansas at any time and never really needed to go to the Emerald City at all. (Can you believe Glinda kept that info to herself for the whole fricking movie?)

In any case, I think the company's dire need for cash before the final analysis will arrive should put us in a skeptical mood with regard to any "signaling" we'd like to see in this press release.

Doesn't mean it doesn't work!

Regards,
Tasty

[biomanbaba]

TOTALLY agree with your position
1) these guys are conservative....when N August tried to move them towards SPA modification as a strategy based only on his theoretical work they told him NO.....NOW the DMC is moving in that direction and THEY have seen all the patient data....this is huge and positive