1st off....thanks for everyone posting on the board. Long time shareholder here. I don't post much but definitely like reading everyone's posts (both short and long cases).
While I'm long and strong (I don't know why any shorts a $2 stock....your only profit can be $2.....besides I definitely want to be in it on the chance that Phase 2 will be half as strong as Phase 1)....But let me get back to my question....I feel like in all liklihood IMUC will need to do a phase 3. Even current management seems to be even trying to message that currently, it's been talked a lot about on this board....I know some companies push for skipping it and we can all name certain company's that have been able to do that....but let's assume we do need a phase 3.....
Do you all think IMUC can beat everyone else (CLDX and NWBO) to market with ICT-107? I mean we have the sites from phase 2 already set up and handling study participants. Based on the last conference call last week it seems management is trying to put in place manufacturing center in place to pump out all the ICT-107 vaccines.....I'm hoping we don't wait long and even dual path ICT-107. Just get rolling with a phase 3 immediately and if the FDA says you can file with just the phase 2 results fine we can put the brakes on it. But I don't want to wait a year messing around with the FDA like SRPT on can I file or can I not file.....
Phase 2/3 is the current recommendation for agents with "orphan drug status" in the oncology community. ICT-107 has had "orphan drug status" since 2010 and has had the best early results: 55% 3 year overall survival (historical control is 16%) and the least side effects (grade 1 rash). I expect incredible phase 2 results. When the NYTimes and CNN write up about progress in cancer that killed Ted Kennedy the stock will go up 0.50 to 1 in one day I would assume? Then they will fast track and combine P3 with continuation of P2 and have completion within a few months.
Sentiment: Strong Buy
Do you really not feel that a successful Phase 2 would not raise the stock price? Of course it will.
How good the Phase 2 results are will determine the future.
Good results make them an immediate target for acquisition and any financing will be at prices higher than you paid. Skipping Phase 3 would just be a bonus.
First off I am long on the stock so I may be a little biased in my opinion. I feel the answer to your question is all dependent on the results. If IMUC shows no benefit then you know what happens. If it only shows a 2-3 month benefit than yes a phase III may be needed. If it ends up being 7-9 month benefit or possibly greater than I feel they will be able to skip phase III. This is one of the most deadly cancers and I feel it would be pretty unethical for the FDA to say "sorry you need to do a phase III" when thousands of lives could enjoy more time on this earth or possibly be cured. Yes I said cured and with this disease that is a pretty stong word. Dr. Yu is a smart man if if the drug is able to eradicate the remaining stem cells than maybe just maybe these individuals could live a very long time. Maybe they would do a conditional approvel and require a non placebo confirmatory trial but I honestly feel they have enough patients in this trial that it would not be needed. Given that said I do wish they would have enrolled a few more patients in this trial to make a stronger case to the FDA just to be on the safe side.
but, soothsayer/ he who sees the future! , did not manish "enroll 278" he could have enrolled 500 under his definition, and that whould not have been enough. too funny.
PS CLDX's rindo is in PIII with mulitple PIIs behind it. no chance 107 skips PIII and longs will be happy if it gets to a PIII.
biotech investing is not a sprint. pick the right horse at the right time and ride it for a few years at least. or if you like you can pick the jockey with a proven track record of riding winners. or even better winning kockey on a winning horse.
They have, in fact, added more patients to the trial. Per clinicaltrials.gov, the estimated population size was 200. But they finally enrolled 278. There were several rumors as to why they did that. One rumor wa that Dr.SIngh screwed up and they had to add more patients.
Nevertheless the trial size is 278. Dendreon's IMPACT (phase 3) had 275 patients and the results led to Provenge's approval.
I suspect that if the situation warrants, they may be able to get the FDA to permit them to add more people to the current PII trial and switch the PII into a PIII. This could be a much shorter route than a new PIII from scratch - if the results are not strong enough to get outright approval just based on the PII alone.