Sorry but there is no way this goes to Phase III if IMUC shows a 9 months or better advantage over the control arm. According to the CC they would have reached 32 events in the 1Q so I strongly feel we will see that 9 month adv. at least by the end of the trial. So do you actually think that the FDA would tell these thousands of patients a year that they will have to wait until a phase III trial is finished? I can year it now "Although ICT-107 appears safe and well tolerated we recommend that IMUC peform a phase III trial to confirm these results" "Our apologies to the thousands of patients who's lives could be extended or possibly cured by this vaccine." Can you imagine the outrage that this would cause and how many lives are at stake. They may make IMUC do a phase III and grant conditional approvel but they will not deny these patients a chance to live.
Sentiment: Strong Buy
Please share why you think a phase 3 will still be needed if the phase 2 shows efficacy and safety. I realize that you are a NWBO long and good luck to you but you need to be realistic. I understand that it would be frustrating for you as NWBO's trial has been going on for several years now but dont kid yourself. We are not dealing with finding a treatment for dandruff here. This is one of the most deadliest cancers out there and you are going to try and tell me that the FDA would not provide approvel based on good stage II results.
Sentiment: Strong Buy
Yes, once the safety board and interim analysis confirms go ahead there is no way backwards...they either kill it at interim or never.
In addition, as I pointed out before the total patient population is 12,000/year with an average survival of 15 months. That is why we have an orphan drug designation. What patient size would suffice for a P3 if the total patient population is way too small...the P2 enrollment was already fantastic and speedy.
On another note though what still bugs me is the fact that they supposedly calculate their model with a 18.8 OS for the control arm and still expecting 32 events in Q1. (Let's not go into the argumentation now that they say Q2, as they only say that due to several weeks of data collection, analysis etc. the interim would fall into Q2 and not the 32 events). So I just do not get their maths as nobody on this board came up with such timing assuming 18 OS for the control arm let alone 18.8.
In my view the only plausible explanation it has to do with the tail effect of having the immune response with a delayed response and not show enough efficacy at the interim.
The only other thing I am just scratching my head over is the cash burn being the same for the future in spite of the new trials. Hopefully the CFO knows what he is talking about.
Again, I am only invested in this stock right now and 100% of my trading account - which is very rare. I only did it with ARNA and KERX.
I believe the CFO regarding the cash burn as ICT-121 and ICT 140 are only treating 20 patients in each and the vaccine is reletively cheap to produce. You would also think cash burn would be higher for the ICT-107 trial during 2012 as they were busy with screening procedures, initial dosing, etc... I'm definetely no expert but I feel that they will burn through less cash this year in the ICT-107 trial as they have already done what I would consider to be the "hard work"
Sentiment: Strong Buy
Agreed, the only Phase III/IV will be post-approval marketing studies in the US and Europe and to those lucky enough to make it in these "trials", it will be available to patients with recurrent GBM to see how it responds under those conditions.
No ethical committee nor any larger number of patients would agree to a p3 if p2 proves statistically significant OS benefit.
They would have to find a scientifically valid question to be answered in a p3 other than OS compared to today's SoC alone in order to convince ECs and pats to participate in a trial where not all patients get access to the best treatment option.
I will also add nostradomus that the mimimum efficacy that we are guaranteed at this point, which is a 9 month survival advantage based upon 80% power, already blows Avastin out of the water from what it accomplish it its trial, which was approved following Phase II results.