I think, give or take a little, the best guess at this time is that we have at least 9 mo. over the SOC. If in fact this proves to be true at the end of the PII trial, will this be enough to get FDA approval without a PIII or at least and approval subject to a parallel PIII post approval or perhaps allow compassionate use. I clearly hope this is the case but I am curious of what the general opinion on the board is. Basically, is 9 months enough to convince the FDA?
I would hope so not only for my investment but for all those suffering when their life can be extended. I trust the projections of IMUC management. We are getting closer to the end of P11 and hopefully the results will be enough for at least compassionate use. GLTA.
We still need to be a little careful about the assumptions. If we assume the control group has no more than 18.8 mo OS and the 32 events happened not earlier than April - I think both assumptions are realistic - then we have at least 9 mo benefit. I think we are closer to 11 mo. This is also in line with management expectations. They seemed to be pleased with the results. The safety concern is already out of the way.
I believe that anything in the 8-9mo or neighborhood OS benefit would give us a fairly good chance for early approval. It would be silly from the FDA not to approve it as it approved other treatments after P2 for much less or no benefit.
Contrary what many say I think it will be approved after P2 and a post approval P3 might be required. ICT-107 already classified for orphan drug status, GBM is a very lethal disease with little alternative treatments on the horizon and ICT-107 addresses unmet medical needs. My question is the opposite : why wouldn't the FDA approve this vaccine after P2 in case of a 9 or more OS benefit ? Smith mentioned the two sites manufacturing sites issues. I would accept that reasoning for an ordinary disease where competing drugs are already on the market etc. However, this is clearly not the case here.
I do not think the company is as far along in their models as those on this board. Initially, they were projecting an end of year 32 events. Later they begin to talk about Q1 and then news in Q2 about an event at the end of Q1 yet, they are still saying end of year for 64 events. That date simply must shift the same number of months and maybe more than the first milestone did.
1. They are completely blind to the data, event dates, etc. As they should be.
2. They made one projection at the beginning and have not really updated it even though it was made prior to enrollment numbers being known.
3. They are using a range for control survival and openly discussed considering both in their projections.
4. Their numbers for end of year 64 events line up with their initial projections' but not for 4 month shift in the first milestone.
5. These milestone dates, even though we only an approximate time reflect much better than a 9 month advantage, but it will also take much longer than December to reach 64.