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Re: None

Tuesday, 12/04/2018 1:07:54 AM

Tuesday, December 04, 2018 1:07:54 AM

Post# of 8545
Helen mentioned at least four times that the reason behind PFS taking longer than anticipated had to do with censoring. It is not only possible but quite likely that the control patients switched treatments more often and earlier than the pegpH20 patients. Therefore, any of control patients’s subsequent progressions beyond the 14 days after last dose of placebo was censored and not counted as progression. Because of this censorship, the control group may have appeared to have (erroneously) longer PFS. I know they say they are blinded but we know they have clues (side effects like muscle aches and edema) as to which patients are getting Peg vs. placebo. Sensing this counterproductive potential higher or at least equivalent PFS among control group, halo proactively dumped PFS interim analysis. It is actually a smart move.

The key is that she mentioned the OS time frame is going as expected. Otherwise the IDM committee would have stoped the trial for futility.

Another interesting clue was that at the beginning she introduced the new Chief Commercial officer for oncolgy. He was not meant to answer any questions (having no involvement with the trials and being new). I think this was a subtle clue as to Helen’s level of confidence with Peg.

I still think they should partner/sell the pegph20 rights ex-usa, get breakthrough designation from FDA and do some insider open market share purchases. Any 2 of the above 3 will send the shares into all time new highs ($25-$35).
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