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pgsd

09/25/17 10:36 AM

#136300 RE: Evaluate #136297

IMO your last statement implies exactly that and the "vagueness" is not coincidental.
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gropgrip

09/25/17 10:44 AM

#136302 RE: Evaluate #136297

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
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sentiment_stocks

09/25/17 10:49 AM

#136303 RE: Evaluate #136297

Hmm. I still do not see how "embargo" explains the very vague 8K.



What is the point of Linda speaking at a conference if there's nothing new for her to share?

Interim??



To a certain point in time data.

I thought we were awaiting word of data lock and "final" results ... not merely some kind of interim results.



Well... we are. But there it all gets a bit fuzzy - meaning exactly what is to be data locked and when is it to be data locked?

I am also still confused about this report that Bosch has hinted at.
If this report is only going to do some "analysis" on blinded data, how much impact or how detailed could this even be?



Well this all my opinion of course, but the fact that the company is anticipating "interim blinded data" strongly suggests that this will be the content contained in the report. Given that, it's likely Linda thought this "interim blinded data" would be out by the time SMi rolled into town, and instead, it's not. As for how much detail and impact it will have, I would guess that would first depend upon the actual "interim blinded data" shared; and second, what the impact factor is for whatever journal it's being shared in.

Does this imply we will need to wait "a lot longer" before final & unblinded results will be reported?



No necessarily. But it seems we do have to wait for this "anticipated" publication with "blinded interim data" before the company will fill us in. Perhaps they think the investigators are better presenters and will receive a wider listen than if the company said it first. No one wants Dr. Buzdar to show up again, do they? I think the shorts schooled Linda on that one. No rosy colored glasses allowed around them!