Are you serious?? Every question you asked you would not get a response on. Phase 2 decided by events not CEO's choice. Would not say what FDA may or not do, still a long process. If data good will expand trial Phase 2 trial first. Never hear CEO say where the PPS goes or what it should be.
How about some serious questions, like How are the Phase 1 patients are doing today. Already closed trial but bet they do keep tabs on everyone and could possible give info but would expect hearing about the good events not bad.
Long. And waiting on ASCO in late May
1) if already the planned interim analysis in Q1'13 is positive (meaning statistically significant difference between the experimental and the comparator arm), we will have top line results (qualitative) in a press release and the full (quantitative) data set probably at ASCO'13 beginning of June. If the interim reveals that the trial is futile we will also be informed and the stock will tank. In the most likely scenario that the trial continues (statistical significance not yet reached but clear separation of the curves), there will be no data before the final analysis end '13 beginning '14
2) If the ph II is positive, a ph III is very unlikely - in fact, as stated before, it could be deemed unethical to run another trial where some patients would have to be randomized to an inferior regimen. Also, given FDA's recent push for "breakthrough" filings and reviews, ICT 107 would likely qualify for this category and a filing would be acceptable by FDA based on this randomized ph II data
3) Anybody's guess, but I would not exclude 10 to 20x today's MC. This treatment is for about 50 to 75% of all 1st-line GBM and we have a hitherto unexplained screening to treatment ratio of another 50% in the trial. If that is for medical reasons (meaning e.g., future contra-indications), we would be looking at a 25% to 37% target patient population of untreated GBM. Also, ICT 107 would have to be partnered as IMUC is running the development largely as a virtual company and has no organization to commercialize the product on a global scale. Thus, they would have to share the success.
My rating remains: Buy! - but it is a speculative investment.
Disagree on portion of point #1 and pushing expectations on top-line outcomes way to soon, in my opinion. However, if this does take place...WOW! Regardless, submissions for ASCO abstracts are closed for 2013, except "Late Breaking Abstracts". I am not saying impossible, but am stating that it would be a herculian task to submit in the first place, have ASCO accept results on a partial population of only 32 events, AND would require eye-popping results. Again, this could happen, but???? I fear that everyone's excitement will harm the potential for this treatment and company alike if expectations are set too high. Let the data unfold and recognize that ICT-107 is a treatment with remarkable potential. I also agree with Toublesacomin comments in #3 below as well.
2 )will ph 2 results be enough for eu approval?
3) i dont see a partnership, the ceo has said they are going to build a facility. it doesnt make sense to build a manufacturing facility if you're going to do a partnership. the pipeline is also too strong anyway, gbm, ovarian cancer and 121 is too much to give away. by the end of 2014 they will have these drugs in middle/late stages. I'd rather take another stock offerings than partnerships. and im sorry to say, thats whats going to happen.
and i dont think of this as a speculative buy because i dont think the early results were a coincidence and the doctors like Black wouldnt go out on a limb and risk his credentials.
if you are asking, you shouldn't be in any stock. Duck has the right idea, much of the info is on the
IMUC investor page. Recent conferences presentation and conference call are available, good luck.
if anyone told me a stock would go up so much i would question their reasoning then after examining their thinking would probably but nicely call them a fool for expecting such a return.
Helps to get insight from longs on this board, it is great that we all make money and help our economy. I'm sure you are a hard worker and investing luck to rest of us and earning a paycheck through hard work and not living off of the gov.
Sorry, didn't want to get into a rant.
GLTU and all longs.
Sentiment: Strong Buy