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kris_kade

01/23/13 6:52 PM

#8553 RE: sdtrond #8551

If I may, I think LTG has a good point. He was referring to the management's take on RFA PFS. Albeit historical number, they must have a very good basis for reiterating the number '12' not once but multiple times and that too on CC.

They indeed would be very surpised to find it's 50% more. Not that I am holding them to their statement but they too must have beaten this to death before they repeatedly made that statement.
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kris_kade

01/23/13 6:53 PM

#8554 RE: sdtrond #8551

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

01/23/13 7:09 PM

#8559 RE: sdtrond #8551

As stated in the Q2 CC and I confirmed with IR directly, CLSN knows exactly how many people died and how many had treatment failures (or at least 2nd doses).

There's a lot of trial info that they do know, despite being blinded, that is quite valuable and gives them a better clue into the results.

Being blinded makes it difficult for them to draw any conclusions unless....

....unless the data is overwhelmingly strong. For example, if they have a big percentage of treatment failures, knowing full well how strong that lowers the average/median PFS yet the PFS is still well over 20, that suggests if not proves something really huge going on. Another example is if treatment failures are in line with expectations -- or even worse -- yet the PFS is this huge, then ThermoDox working in their minds becomes an instant no brainer.

Unfortunately we don't know WHY they are so confident, but there's a number of scenarios possible that make their confidence justified to the point of virtual certainty.