So we get final results at the end of Q2 2014. If we haven't done the ATM, we do it then. Then we schedule a meeting with the FDA to figure out what to do. The result of that meeting is that we decide that the results are compelling enough that we need to bring this to a vote through the doctors. We schedule a FDUFA date, then schedule a meeting for the doctors to vote on this, say I don't now August or September? The results of that meeting is that we unanimously vote to recommend the stock for approval. However, the results of that meeting are that we also recommend which Phase III trials should be done regarding this stock on a post-approval basis. I'm thinking that there is one Phase III trial with ICT-107 given concurrently with Rindo in the approximately 18% of GBM patients that are both HLA-A1 or HLA-A2 positive and EFGRvIII expressive. I think we fill enrollment of ICT-121 towards the end of this year, maybe a bit later. By the time the meeting comes out, these patients will be about 9 months from enrollment for the latest patient, meaning that if you have recurrent GBM, you should be dead by then. At that point we also decide whether ICT-107 should be given with ICT-121 in a Phase III post approval trial as well. The recommendation is that ICT-107 should be temporarily approved for non-recurrent GBM patients that are HLA-A1 and HLA-A2 positive with evaluation as to the performance of the vaccine on recurrent basis or on a current basis with Rindo pending the results of these Phase III studies. At this point, the FDA will take some time to mull over the recommendations of the physicians, and will begin to ask Dr. Yu to draft Phase III post-approval studies as suggested in the PDUFA meeting. Dr. Yu drafts the studies as requested in communication with the FDA, and submits then for approval in conjunction with recommendations. Sometime around the end of the year, the FDA sends the letter of approval with their conditions.
Although I agree with a lot of what disco posts, I think his timing above is too short. I think it will take longer to gain FDA approval than the end of next year.
I posted on March 1st that I thought the NDA would be submitted with a Phase IIIb study run in parallel. I still believe this will be the case. I don't think the Phase III study will be post-approval. If results of the current study are available in Q2 of next year, then the End of Phase II meeting with the FDA will be held in Q3/Q4. If the results are as good as we all think, then this meeting may also serve as a pre-NDA meeting. If not, then I'm sure one will follow very shortly. In any case, I don't see the NDA being submitted until Q1 2015. This would lead to approval in Q3 2015, assuming that the application receives Priority Review (as opposed to standard review). If priority review is not granted, then approval would be in Q4 2015 or Q1 2016.
We still have a long ways to go.
that they are expecting us to continue with our Phase III(b) trials? Sounds like we are having a semantic discussion.
So let's total - June-July 2014 for results
August-September 2014 for End of Phase II meeting to discuss results
October-November 2014 for submission of NDA along with proposed Phase III(b) trials - for 6 months priority review
January-February 2015 for Advisory Committee Meeting
March-April 2015 for Approval
Thanks for the input.
I think my timing is a bit short too, but for different reasons. I think it will take more time to prepare and deliver the final results following 64 events that I haven't accounted for. I think the turnaround time from the point of the drafting of the results to the End of Phase II meeting will be around 2 months. I don't think it should take longer than that, and 2 months allows plenty of time to read, analyze the results and produce recommendations. I think the first part about the studies being run in parallel is the same thing as what I am saying. The only difference is you are stating that we will draft and start Phase III(b) prior to hearing results of the NDA. Either way, you have to draft the studies for review when you submit to the FDA and you are stating that in this case (if the results are as good as we think) approval is not based on the condition of the Phase III(b) results. In other words, we are both stating the initial approved label is for non-recurrent glioblastoma only as that is all that has been tested thus far, and that the expansive label is based on the results of a Phase III(b). Perhaps it will take longer to draft the NDA following the End of Phase II meeting than I originally listed since along with NDA, we would have to draft proposed studies of Phase III trials. However, I don't see it taking 6 months for Dr. Yu to write an NDA and draft the studies. I just don't see us being caught that flatfooted. They might tell us that to remain conservative and to give themselves leeway time, but I see the turnaround time of the crafting of the NDA being another two months.
Now, with regard to Priority Review (6 months) vs. Standard Review (10 months), I don't see waiving Phase III results of a condition of approval because you want to take 10 months. Oncology drugs/vaccines should be 6 months, particularly for deadly diseases. Also, with regard to in-parallel vs. "post-approval", doesn't the FDA still mention in the approval letter
In Phase I clinical studies, ICT-107 showed highly promising results that took many experts by surprise. Progression free survival after two years was 49.2% compared to 10.7% with the standard of care, while overall survival after 2 years was 81.2% compared to 26.5%. These results also surpassed other treatments in development, from Celldex’s CDX-110 to Merck’s Cilengitide. The company began its randomized, double-blind, placebo-controlled Phase II clinical trials in Q1 2011 and should report an interim analysis of these results in Q4 of 2012.
I think that if the P2 results show right there will be an approval for treatment and a P3..regardless with positive P2 Goldberg can stick his 1 dollar bill where the sun don't shine..we will never ever see $1. I pray that this science is as strong as I think. Just say'n. GLTA..
been over this one already with the approval stuff. you see what similiar companies have selected to do and their share price have still appreciated nicely. i think you're wrong on that assesment, but we will see.
yep agree, 107 results end of q1 2014 beginning q2 2014.
no, its only 20 or so people, enrollment completed sooner. Not surprised if they have the candidates lined up or have a few of the people in their sights before that announcement. this trial is also a priority, the trial wont be a burden to alter their finances
it will get done as quickly and effectively as possible.
“We believe that 2013 will be an exciting year of progress for ImmunoCellular, and for the field of cancer vaccines, which has the potential to significantly improve clinical outcomes for cancer patients,” said Andrew Gengos, ImmunoCellular Chief Executive Officer. “We appreciate the broad support for our development programs within the medical oncology community, and look forward to advancing our programs and strengthening our position as an emerging leader in cancer immunotherapy.”
FDA is most likely to ask for a Phase III study, which will take another 3-5 years. Don't bet on an FDA approval before 2017 if you don't want to be burned badly. By then, there will be so much dilution that this stock will be worth around $1.
You know nothing dude. You don't even care about this stock. You pump to everyone saying how great it is without any sincere interest in owning the stock, then bash to dump and short the stock without any real feelings or insights either. You simply don't give a #$%$ to bother to do all the analysis that many of us have done over months. You haven't read or analyzed any of our spreadsheets or our posts over many months, nor do you remotely understand how oncologists or neurosurgeons think. Why? Because you don't care. You are just a messenger and a puppet of an ill-informed master.