Before I break into the analysis, I would just like to update readers that the February 10, 2010 ODAC meeting has been delayed due to extremely bad weather in the D.C. area (link here). Take it from me, we are expecting another 20 inches of snow tomorrow and we already have two feet on the ground. Now on to the analysis.
I have to say this is one of the more difficult drug approval estimates I have had to give in quite some time. On the one hand you have pretty clear evidence that Pixantrone helps patients, and on the other there is also evidence that cardiotoxicity exists. So the real question we are talking about here is does the benefit outweigh the risks?
So what is the Approval Estimate?
As I previously stated in a prior post, I thought Pixantrone had a 50/50 shot at approval. I’ll get right to the point here, I still think it has a 50/50 shot. With the release of the briefing documents today, I thought there might be some data that I wasn’t aware of included in the documents. But there wasn’t really any new information included in the FDA’s analysis of the drug. And as I predicted in a prior post, some hack writer wrote a really negative article the minute the briefing documents were released so they could get headlines (Read that post here).
Most investors in the company however, were already well aware of the information released in today’s Briefing Documents (here). And since I’m not changing my 50/50 approval estimate I will simply post one that is similar to the one I proposed in an earlier post (here).
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Thank you for writing a fair assessment of where CTI stands with PIX. I invested a fair amount in this drug based on investment factors, and not medical data, and it is refreshing to read SOMEONE who writes without an agenda.
You didn’t mention anything about the study being a CONTROLLED clinical trial. Oncologist either treat these patients with palliation or a whole slew of drugs at reduced doses for the very fact that there is nouthing else for this group of patients. There is no other controlled trial and that’s a big deal.
Thanks for the great review of today’s CTIC briefing notes. I really appreciate your unbiased reporting highlighting the pros and cons as you see them. There are other Biotech reporters that just promote the hype, (and yes we all know who they are). These pure hype reporters are frankly just petty and exhausting to listen to.
Many thanks for your excellent work!
Thank you for your review of CTIC. I’m watching this stock nowadays.
I think I can get some at very cheap price tomorrow.
Well done, once again. Thank you very much for all your time and effort in composing your thesis. It’s really well thought out and conveyed in a manner that is easy to digest for those of us who are not able to see the forest through the trees when it comes to some of these stocks. Many thanks, mate.
Nice analysis, thank you. It confirms some thoughts of mine while reading the FDA briefing.
I do not see where you address the HITT criteria of patients and how that may effect data.
The FDA tells you what happens when you remove patients.
“””” That is, while the p-value for the primary analysis is 0.021, a change in the assignment of response for even a single pixantrone-treated patient who achieved an IAP-determined CR/CRu would greatly affect the level of statistical significance.
For example, 1 less CR/CRu on the pixantrone arm would have resulted in a p-value of 0.036 rather than 0.021, while 2 fewer patients with a CR/CRu would have resulted in a p-value of 0.06.””””
The FDA also tells you that 5 CR/CRu’s came from NON-aggressive NHL patients.
“”"”"Among patients with a non-aggressive histology by central review, 5 patients on the pixantrone and 1 patient on the comparator arm achieved a CR/Cru.”"”"
IF “”"2 fewer patients with a CR/CRu would have resulted in a p-value of 0.06.”””” IMAGINE THE P VALUE WHEN YOU REMOVE 5 of them ?
This trial was done with HITT criteria specifically to have AGGRESSIVE NHL Patients. I find it doubtful the FDA will consider combined Aggressive and NON aggressive data.
Mentioning also that The FDA tells you that 28 NON aggressive patients were let in the trials.
“”"”A non-aggressive histology was found, by central review, in 12/64 (18.8%) patients on the pixantrone and 16/66 (24.2%) patients on the comparator arm.”"”"
Mentioning also the FDA tells you
“””Note that almost twice as many patients discontinued due to an adverse event (AE) in the pixantrone arm compared to control, ”””
As well as other GEOGRAPHIC concern
“”"”"Of concern, no patients enrolled in the US attained a CR or CRu. “”"”"
So you ignore the HITT criteria, the Large difference in discontinuance due to adverse events, and the Geographic Issue… don’t let the geographic issue fool you. It is a BIG concern as far as I am concerned.
Finally you did hit the nail on the head here “On page 5/15 in the Briefing documents released today, the FDA reviewers note that the low enrollment is due to “investigator reluctance to enroll patients and many investigators preferred to use multi-agent chemotherapy or supportive care in this 3rd line population.”
THERE WILL BE NO FURTHER TESTING
THIS IS THE END
Even if the FDA said we approve with phase IV testing, NO ONE WILL PAY FOR THE PHASE IV TESTING.
THIS IS THE END.
Well just my humble opinion of course.
Good luck to all.
I’m sure there is something rotten underneath, but the news was not all been negative so far, as well as the entry of institutions / institutional funds, with purchases of a certain size and at a very high price (thinking now ) This is perhaps again the nth bluff? And these agencies / funds because they bought at high price? Ok to the heart (it could not fix !!!), good for only 140 patients against the 340 required by the FDA (but the same FDA has given the OK to experiment even for 140 patients). CTIC force, the road is just not give up, do not you kill so many people waiting for your medication Do not think of profit, the money is alone and will be many, focus on medication please. Lou Italy (my email / msn is: monox62@hotmail.it)
Dear GC,
Need some help over here.
Why did the FDA briefing and CTIC briefing didn’t reviewing the 18 months follow up data.
http://finance.yahoo.com/news/Pixantrone-Produces-250-prnews-3456496926.html?x=0&.v=1
If they are referring the 18 months follow up data, the CR/Cru 25.7% vs 7.1% (p=0.005 < 0.0096) then the primary analysis is significant.
With all the data improving, the data will magnify the benefit bigger than the risk
Thanks & Best Regards.
Ivan
I give it a 20:80 Chance of Approval (20%)
i have read your analysis and find it informative. Let’s remember all drugs have side affects an d there are inherent risks involved . The fda has passed drugs with similar concerns , in the end finding the benefits to patients and requests for the treatment strong determinative factors,,,,,,,in today’s environment and ongoing strives to eradicate cancer this drug must be allowed , for it is the patient taking the risk , often facing death , its a risk most of us wouldn’t hesitate to make
were the new CTI documents ever located? CTI CEO mentioned there was newly available information from them.. after the FDA doc came out…
?
Sorry, I didn’t see your post. Just refer to the same FDA page that the regular briefing documents are on, there are two sets of briefing documents under Cell Therapeutics.