As more time passes I think its getting very hard to hold a point of view that the vaccine isnt working, even factoring in the possible month delay from the 32nd death occurrence to public report from IMUC. I think its also very apparent that the chances of FDA approval on this survival data from the P2 is also a false hope that should realistically be dropped from our thinking. Regardless of what anyone says here......... the stock is barely worth $2.50 taking into account the fact that major dilution will need to take place over the next 2 years to fund a P3. The company has sort of already hinted at a P3 being probable, we know Yu wants to go it alone, we know IMUC is years behind NWBO .......... so look for the pps to even drop even further after topline results are out in 2014! Look like there will be plenty of time and oppurtunity to buy shares in the next year. Probably a great investment for my grandkids.
I think it kind of goes like this.
1st event: IMUC interim results demonstrate extremely significant increased survival (although they are only allowed to say the study will continue)
1st response: IMUC board, retail investors and some institutions establish new pps level at 2-3 times current price, they will rightly anticipate 64th event will be nixed and trial will be stopped to allow all participants to be treated.
2nd event: NWBO will start announcing results of unblinded DC Vax Direct trial to the extent they are allowed in the third quarter.
2nd response: NWBO board, retail investors and some institutions establish new pps level about equal with the now higher IMUC Price.
3rd event: IMUC trial is halted to allow all trial members to be treated with ict-107.
3rd response: Massive institutional investment causes IMUC pps to skyrocket to 30-50.
4th event: FDA states that it is considering approval based on current data and new laws which allow non phase 3 approval. Will require 3rd and 4th phase post-approval trial on absolute timeline.
4th response: Shares break though 100.
5th event: DCvax-l and DCvax direct trials are also stopped for humanitarian reasons to trat all participants.
5th response: NWBO breaks 100.
6th event: NWBO is ready to launch global production immediately, but IMUC states it still has 6-9 months until launch is possible.
6th response: NWBO breaks 200 and IMUC hangs around 80-100.
7th event: Big pharma Bristol...Merck and Roche get FDA to lower their trial requirements even more (through various legal but strong-arming techniques) and all announce they anticipate approval after short phase 1 trials.
7th response: NWBO stays around 200-225, IMUC drops to 75, and big pharma moves up approximately 25%.
8th event: Reevaluation of available trials demonstrate NWBO somewhat more effective than all other immunotherapy medications.
8th response: NWBO splits 3 to 1 and moves back to 200 within days.
Keeping in mind that phase I results were obtained with just 3 vaccinations in the first month of treatment. This trial fills the following 11 months with additional rounds of vaccine. (And follows that with more at 6 month centers). If you conclude that it is working, then the next logical conclusion almost has to be that it will work better than it did in phase I.
There should then be two characteristics to the phase II results.
1. A higher percentage of patients showing longer durable result (which I think is a sign of complete response)
2. A longer time before progression in those cases where did not get all of cancer.
The first trial patients either showed long lasting result or progress in that was significantly delayed.
Consequently, I think Dr You is conservative in his 9 month advantage estimate by a long way.
jet what bothers me is they do not know what mechanism of action is yet...it surely is not type 1 cytokine responses since another vaccine was made that is very similar and only has 9% response rate
Listen to the cc again. Particularly, Cash on hand, the ATM offering, burn rate(1KK/mo..) and projections for the BR.. "Over the next two years", and then some, is already in the bank.
Seattle Genetics received accelerated approval of Adcetris after phaseII, but was still required to do a phase III. I think the company would be more than willing to do a phase III in that scenario.
Really?!! How is then Avastin got accelerated approval after PhaseII? Google it and maybe you find out. We are talking about a rare disease here and if patients on ICT107 arm live significantly longer than SOC patients, how can you justify the necessity of P3?
I agree that the vaccine must be working. I disagree about your timeline to success. Currently IMUC has a positive net worth and will do so even with the ATM. Diluting to even 80m shares is miniscule knowing what might be in store for IMUC. Good results will skyrocket the stock just like the many others (too many to list) that rise with good P11 and P111. We have all seen those types. Why would IMUC be any different with good results? Yu wants to go it alone but that could change at any time. Let's get the results first and then speculate on the future of IMUC.
Sentiment: Strong Buy
accelerated approval is not a false hope it is quite likely...long term survival efficacy in a subset of patients in an orphan disease is priceless in terms of medical advances
this stock will double some time after interim in my opinion