one month to unblind bnc105 p-2 data

The primary outcome is a bit tricky. From clinicaltrials.gov,

Primary Outcome Measures: •Phase I: To determine maximum tolerated dose and toxicities of BNC105P in combination with everolimus. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

•Phase II: Improvement in 6-month PFS with the addition of BNC105P to everolimus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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Estimated enrollment 152.

Considering it is a short timeframe (6 months), the curves may not separate much. In other words, if everolimus is effective, very few patients may die and/or experience progression in the disease.

For BNC105 not to be a dud, first thing is that the curve of treatment arm should at least track the control arm. If control arm is showing better PFS or less mortality compared to treatment arm(BNC105+everolimus), it will be a disaster. I am not sure of IMDB (independent data monitoring board) was authorised to follow the trial continuously and stop if such pattern was observed.

Now for BNC105 to be hailed as success, the curve (BNC105+everolimus) should stay well above the everolimus-only curve. I dont believe they are looking for statistical significance (usuall p < .05) in this trial. So just the separation of curves will lead to phase 3. More importantly, Bionomics would "graduate" in biotech world with such positive coutcome.

Depending upon my gut instinct and the stock price movement in the next 30 days, I may take some off the table. For now, I am just on pins and needles. This is going to be a really big deal for the company and its future.