For months, you guys, Eves, phishes, ducks et al have discussed survival curves, SOC, P1 results, mgmt patient analysis among many other issues. We now have had 32 events - some say earlier than expected, others say about as expected and others say later than expected.
Now and then, senior mgmt will ask what is your best estimate based on all the intelligence available. They don't want qualifications, assumptions, if this or that happens.
How do you think ACT 107 is performing in its P 2 study vs SOC? Is it providing a meaningful and measurable benefit?
It sounds like most of you agree that 107 will be required to go to P3, mainly because of the 2 manufacturing cites' issue.
phishes3, ...........my thanks to you and "the usual suspects" -
This IS immune therapy, and results might fall into a holy grail category. I like your paper [as yet unpublished, ha] estimating a 6 month advantage. The allovectin-7 trial has run much longer than planned. The start trial, check out the subgroup data. 800 of the 1500 enrolled patients received cCR and tx drug - A 50% increase in OS. 20mo. vs 30mo. Trial failed but Merck KGaA says "ongoing negotiations with regulatory authorities." - FDA will want another trial, -dam,,n
•Prespecified subgroup analysis identified significant 10.2-month OS benefit with tecemotide in patients who received concurrent initial chemotherapy and radiotherapy
Now, the fun part. [sarc] - we will hear nothing about the ict-107 trial for the next 6-8 months. One morning we wake up to the p.r. online, before market open of course. The results for all to see.
It is never as simple as stating just one number... the midpoint of my normal distribution of outcomes says 8.5 months of benefit, I'm investing based on my "final prediction" of at least 5.8 months of benefit based on a 80% probability from my data set. One thing that bugs about these numbers is that this would be like the holy grail of cancer treatments - even at ~6 months additional benefit that is around a 25% improvement in OS which is very rare. I can not find anything that is way out of line in my model/assumptions and it is consistent with others models on this board. I can pick apart the P1 data and find things that seem to stack the odds for the trial and additional OS but they do not explain all of the additional OS and my P2 model does not use any of the P1 data in it's assumptions. In the end I'm forced to believe that there is a high probability that the trial will be successful (not 100% but greater than 95%). In my opinion there is no point in being for or against a company when investing... facts (good or bad) are the only things that matter.
5.8 months means a full blown P3 and only a 25% chance of those P3 results being good enough to pass FDA approval, Thats 2+ years of rock bottom dilutions. Face it, weve been sold a pig in a poke. IMUC is worth about $1 at this point, massive dilution ahead, 3+years away from possible approval, other treatments in clincial trials probably will surpass 5.8 months ( this dendritic technology is being explored by many companies now) . My advice........ sell now at $2 and fell lucky when the price drops below $2 in the near future.
Bottom line is that the OS benefit will be 9 to 12 months for the treatment group vs. control group. Final phase II data probably not available until March-April, 2014. Phase III required....mmm that is up to mgmt. and FDA...I would say 2 to 1 in favor of a phase III required.