Obviously, anything about projected timeline for 32 events. As well as process for declaring 32 events? (Does this get checked on a daily, weekly, monthly, etc. basis?) How quickly after IMUC knows they've reached 32 events will they release this information? What else?
Like Avastin if Phase-II data sufficient to satisfy FDA on survival ratio more than 50%( Which is) FDA might grant Fast Track APPROVAL for IMUC’s dendritic cell-based vaccine, ICT-07, which completed Phase IIb clinical trial treating newly diagnosed patients with glioblastoma multiforme, an aggressive, terminal form of brain cancer.
Remember this is PHASE-II B under US-FDA directly monitoring clinical outcomes.
Sentiment: Strong Buy
Ask them: If we have twice as many placebo deaths despite having half the number of patients (placebo group is dying 4x as fast), will the FDA consider stopping the trial upon interim analysis and moving straight to the NDA phase?
Thanks for asking these questions. I would like to know how is the trial doing so far.
1. How many events occurred in placebo group till now.
2. How many events occurred in control group till now.
If it is not possible for him to answer this question. Get a total of how many events have occurred till now. This would give an idea of how long this may take.