I respect that clinical significance has value in assessing...

I respect that clinical significance has value in assessing effectiveness of developmental drugs but I would have been more comfortable if the p value was closer to the pre-specified 0.10 level from a statistical perspective and marketing perspective. It's arguably better to signal to the market, e.g. "PFS HR almost reached statistical significance" and describe the limitations of sample size than to indicate that it was way off, i.e > 0.20.

This is quantitative research and there's a few other challenges:

• The market may not understand or care about clinical significance and equally statistical significance (not everyone about dry statistics) which makes it difficult to predict how the share price will change based on the Imugene announcement. We talk about statistical and clinical significance in this forum but honestly, retail and institutional investors might potentially be apathetic or have no knowledge of.
• Commercialisation of drugs, say, Herceptin would probably not have been approved without a sufficient statistical power, sample size and statistical significance to demonstrate that the superiority of their drug wasn't due to chance and could be attributed to the drug. I can't imagine the FDA approving a Phase III study on the basis of clinical implications if there was statistical significance. Happy to be corrected.

All this is to say is who knows? Perhaps investors might narrow their attention on the PFS HR only and purchase more shares. Perhaps investors might buy more in the hope of positive OS news. Perhaps big pharma might view this as positive or negative.

I view this announcement as a slightly negative (yes, a revision to my previous post) one and no, I'm not downramping. There's just something that doesn't sit well with me knowing that their study fail to achieve statistical significance especially when they chose to reduce the sample size based on the committee's decision. I made a mistake expecting that the PFS HR would have been lower than the ToGA but it was not and I was disappointed. I will still stick by statistical significance as an important indicator of success despite many large acquisitions of small companies based on measly pre-clinical results.

DYOR.