umiak,
Don't you agree that there are varying degrees of positive news?
For example, they PRed that ABLATE enrolled the first patient. Good news, it certainly is not negative, right?
They PRed that a HIFU trial was agreed on and would start early 2013.
Better news, right? We already knew ABLATE would happen, having verification of enrolling was good. But this was a totally different indication that seemed to take forever to get off the ground, so this news is *better*.
In a similar vein, knowing the FDA requested we skip ph2 is "good." Knowing WHY can let us rank how important it is.
LTG seemed to indicate that by itself this was very important. I attempted (in a very poor way) to say it was good-but-not-terribly important.
Let me try again.
I misrecall the exact post but at some point LTG said in his conversation with Jeff, he was told the FDA recced to skip ph2.
The reason given, that it was urgent to find a good treatment for HCC, is adequate but not important.
I'll go further. Later LTG said that the ph1 data was good enough to skip ph2. I'd like to know if [edited, got mixed up: LTG's words], or if those were Jeff's precise words.
IF Jeff said the FDA advised skipping ph2 BECAUSE the ph1 data was that good, then I agree this is of paramount importance.
BUT - if Jeff said the FDA advised skipping ph2 because it was urgent to find a good treatment for HCC - I'd argue it falls in the good-but-relatively-meaningless category. ANY treatment that has good ph1 data in HCC should therefore skip ph2.
I proposed an alternative theory, that FDA recced skipping ph2 because the ph2 and ph3 would be the same protocol, just with a larger N in the ph3, and therefore IF HEAT is successful, we's save about 2-3 years. THAT would qualify as meeting the urgency of finding a good Rx of HCC.
I probably lost 2/3 of you and I really don't care to argue anymore. We're (mostly) bulls here and all want HEAT to succeed. We'll know within 1 week, and I probably will simply spend the entire weekend starting tomorrow at noon in blessed ignorance of ALL social media conversation about Celsion, expecting a PR on Monday morning.
GLTA (except shorts)
Trond
