Monday, September 25, 2017 10:44:40 AM
I really don`t think that paper (= preliminary analysis) is anything else than that interim report from the filing. I don`t think it is vague, I think it is just concise. If they even refer to SOS and use countdowns for their webcasts, they will also just assume we`ll identify this "disclosure of interim blinded data" as the paper we are also waiting on for month. I think even, they now gave us one more hint what the preliminary analysis is going to be about: it is going to be on blinded data only and not also as many speculated on maybe PFS endpoint that was reached early this year.
I also would like to hear some spec about what impact it could have.
- it could disclose when PFS was reached exactly and when OS was reached
- it could justify why they are waiting longer for more events
- it could start PPS rise by speculation, because the preanalysis is coming from the company and not SOS or Barunuuk (they`d have precise data on enrollment and cross over)
- it could give us information on why there was a hold, and what they agreed upon with FDA, if this was as "untoward" as Woodford said, or a compromise benefiting the trial, this could be quite the good news
- it could make it possible for insiders to reinvest in the company: the combination of disclosing inside information and speculation on good endpoints
- it could discuss PFS psPD problems and how they got a handle on it or how this relates to waiting longer for landmark analysis and third endpoints
- it could discuss and disclose how many placebo precisely crossed over and how they want to deal with this and how this relates to waiting longer, if they decided and how they want to compare dcvax early and late and why they think FDA should go along with it, or single arm vs historical
I also would like to hear some spec about what impact it could have.
- it could disclose when PFS was reached exactly and when OS was reached
- it could justify why they are waiting longer for more events
- it could start PPS rise by speculation, because the preanalysis is coming from the company and not SOS or Barunuuk (they`d have precise data on enrollment and cross over)
- it could give us information on why there was a hold, and what they agreed upon with FDA, if this was as "untoward" as Woodford said, or a compromise benefiting the trial, this could be quite the good news
- it could make it possible for insiders to reinvest in the company: the combination of disclosing inside information and speculation on good endpoints
- it could discuss PFS psPD problems and how they got a handle on it or how this relates to waiting longer for landmark analysis and third endpoints
- it could discuss and disclose how many placebo precisely crossed over and how they want to deal with this and how this relates to waiting longer, if they decided and how they want to compare dcvax early and late and why they think FDA should go along with it, or single arm vs historical
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