Are there any medicos or statisticians out there who can provide...

Are there any medicos or statisticians out there who can provide some details around the following? (there doesn't seem to be any update on the clinicaltrials.com website yet).

1. " HER-Vaxx showed a reducedrisk of death of 58.2% in the HER-Vaxx plus chemotherapy group as compared tochemotherapy alone." Does this relate to a specific timeframe - eg 3 months, 6 months, 12 months, time since the trial began?

2. "the IDMC reported no safety concerns". Would this be considered new information or just confirming what was reported in May?

3. Is it possible to provide a layman's explanation of "1-sided false positive probability of 0.10"?

4. "The median overall survival (OS) for patients receiving HER-Vaxx plus chemotherapy was14.2 months, compared to 8.8 months in patients treated with chemotherapy alone." Obviously good news, but given the CEO's comments regarding "beautiful data", as a medico, is this 5.4 month extension what you would have expected? surprise on the upside? disappoint on the downside?

5. Why would the IDMC suggest shortening the studyby lowering the number of patients? Isn't a phase 3 trial just a bigger phase 2 trial? Or might the phase 3 trial involve HER-Vaxx alone (ie no chemo)? And if so, why wouldn't you continue with the phase 2 trial simultaneously with commencing a phase 3 trial?


Thank you in advance.