I was pretty caffeinated, and it was the first time I ever called in on a CC. I seriously doubt we even have as many as 75%, but its good to be conservative.
The more important thing though, by far, was the creditability of my point that we don't need a Phase III, and that it seemed like that we were planning to get approved after Phase II the whole time. Did anyone get that part or appreciate it?
Most of the questions during the conference call sounded like interns that had to pose a question for their respective firms! Yours were well thought out and sought answers to a lot of questions posed previously on this board. I suspect the length of your questions were attributable to your nerves and your desire to make sure they understood your question. You've established yourself as a credible and thoughtful investor with the powers that be....so no need for the nervousness next time around :-) Congrats and thanks for the hard work.
Sentiment: Strong Buy
Excellent questions disco, I was listening in live. Your questions stand out in length :) and content compared to the crowd. e.g. questions on other trials are nice but it is somehow not the main point for imuc right now.
So it was good to hear the confirmation that this trial is similar to P1 in that fully resection is not impossible and we are probably closer to 75%. That means that being overly conservative in control OS may not be valid and we can stick to the SOC or similar.
Gengos seemed confident and the whole company seems to be preparing for success. The other important info I took was the blackout for insider buys. Gengos and others can not buy shares right now.
I believe the trail will most likely continue after the interim. However, that can put us really behind in timing...anyway at least more opportunity to accumulate.
You did an awesome job! Your questions were spot on! Congrats!
One of the issues I have and was mentioned on the CC was the fact that they switched MFG and it seemed that are unsure of who is going to be the MFG going forward will IMO guarantee a phase 3 trial. The FDA is pretty clear that the trial used for approval (including MFG) will be exactly the same as commercialization. The fact that they switched or added a MFG (I don't know which happened)tosses a wrench into the entire trial from an FDA perspective (who got what drug/placebo from whom, was there a difference in efficacy or safety from one MFG to the other etc...). I may be wrong with all the new FDA "legislation", but I guess it's possible with a conditional approval that may include an addtional trial with a dedicated MFG.
I'm long both IMUC and NWBO. IMUC will have results first which will validate the drug or crash this technology (both companies will crash or soar on IMUC results I feel) and I'm not bashing by any means, the odd thing is, I'm less concerned about efficacy with IMUC than I am about the MFG of the drug. With that said, I'm long both as I feel the first to market is going to have a HUGE advantage over the other company that is needing to play catch up. If the trial results are good and as expected, I feel that NWBO will beat IMUC to approval as they seem to have the MFG sites locked down.
They basically said that they would not have had two different manufacturers if they could not both statistically meaningfully contribute to the trial to not only validate the treatment, but to validate each other as a proper frame of reference. You are correct in interpreting that PCT would be the only manufacturer granted approval for manufacturing for the initial label. Any subsequent manufacturer would have to be validated through additional post-approval studies.
Disco, I just listned to the archived IMUC CC and congrats, you were real cool. You were clear on the % resection and while they were reluctant to admit that the longer the trial continues without the interim event the more likely a good outcome will be, I think it was clear that they do believe it just can not say it. Anyways I am glad I did not try to stand in for you - I would have bunglrd it since I am not as familiar as you are with the statistics.
Lets see how the market reacts tomorrow.
More interesting is how I subtly get them to admit that we don't need a Phase III trial. Listen to how I coax them into telling me the cathartic response that we don't need 300 patients, because what is important is the statistical significance, completely and indirectly invalidating the rationale that 124 patients, even though out of 278 patients wouldn't be enough.for approval, which is the rationale of those that insist that a Phase III would be needed all along.
Great Job! Read the transcript twice. Feel real good about the results. As I had stated , the financials looked good and as expected, no long term debt, positive equity, low outstanding shares, an ATM which is positive and great management. Hopefully we remain under 100m shares when all is said and done. GLTA.
Sentiment: Strong Buy
You were definitely the third dude to ask a question right...I could tell from reading this board that it was you! You sounded ridiculously smart and I liked how they had Dr. John directly answer your question and he said that you were savvy to notice your observation. Its good to hear that the rates are consistent at 75% for both phase I and phase II trials. You definitely know a LOT about IMUC and its good to have someone as knowledgable as you asking the smart and tough questions! Thanks disco. (Lol, your question was like 5 minutes long though haha)
On another note, I got the EXACT same impression as you that without saying it, Gengos eluded to the fact that if the results of this pII trial end at 64 events are anything near what they were in phase 1, the data will trump any questions about where the cells were produced whether it be U-Penn or PCT (NBS) because each of them produced a significant share and results were in line with phase 1. Basically meaning it doesnt matter who they get to produce, the results from 2011 nobel-prize winning TECHNOLOGY will be the same.
With results the same as p1, after p2, they can basically go to the FDA and say "cmon, what more can we possibly do?" and I think this was what Gengos was referring to when he KEPT REPEATING "feasability" of a phase 3 and "what that would look like". The fact that he repeated those words a few times, and for the first time AGREED (while being extremely cautious in what he was saying) with the sentiment that the longer we wait to hear results, the more likely the trial is a success, makes me more confident than ever in this ceo, his direction, and the appreciation of the share price heading into q3. We are going to experience a significant run-up into mid-term results as the ceo has now confirmed that the longer we wait for results, the better. IMHO if we are still sitting here a few months from now waiting for the mid-term results, chances are we are all holding a $4.50-$6.00 stock in our hands.
Sentiment: Strong Buy