Alright Cell Therapeutics investors, today I am going to repost an excerpt from article I had written back on Jan. 19, 2010. The post is a quick run through a couple of hypothetical Share Price estimates for Cell Therapeutics based on the outcome of the FDA’s Advisory Panel Meeting on March 22, 2010.
Now on to the Share Price estimate:
As I have said time and time again, I am 50/50 for the approval on Pixantrone. I am not sure how the FDA’s ODAC is going to decide on this one. I have outlined my reasoning in an article here. Unlike, most reporters I give a factual basis and reasoning behind my beliefs as to which way the panel will vote. As for the Share Price, we have three hypothetical out comes here. I will list them below with a share price estimate next to them.
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I really appreciate your opinions and input, so thanks for posting your estimates and thoughts about CTIC’s potential share price. – Great read!
Did you read the FDA briefing document ?
The Last Sentence (what perhaps reasonably may be deemed a conclusion) is this:
“All of this suggests that pixantrone is indeed cardiotoxic, but no conclusions can be drawn
concerning its toxicity relative to other anthracyclines/anthracenediones.”
- – Is it fair to say that the Great Likelyhood is that if they do not have any conclusions, additional testing will be required ? IN the 90 % chance area that additional testing will be required ?
Lets put it another way.
Did the FDA answer the questions posed to ODAC in their Briefing Document ?
QUESTION:
• The randomized study was stopped at less than 50% of its planned accrual because of poor accrual. Do the efficacy data support accelerated approval of pixantrone for
the proposed indication?
———– POSSIBLE ANSWER
the submitted primary
analysis would not be significant.
The primary analysis was an assessment of the difference in complete response and unconfirmed complete response (CR/CRu) by the IAP in the intent to treat population.
There was no plan for alpha spending for secondary endpoints.
Secondary endpoints included overall survival, overall response rate in patients with responses lasting > 4 months vs. < 4 months, and progression-free survival.
Duration of complete response and overall response rate were exploratory endpoints.
A large number of subgroup analyses were conducted. Given the number of patients who attained the primary endpoint, these results are unstable and subset analyses will not be
discussed.
———————–
QUESTION
• Is the risk:benefit ratio favorable for the proposed indication?
—————- POSSIBLE ANSWER
All of this suggests that pixantrone is indeed cardiotoxic, but no conclusions can be drawn
concerning its toxicity relative to other anthracyclines/anthracenediones.
—–
Honestly, what is so hard about:
"NO CONCLUSIONS CAN BE DRAWN"
It appears quite simple:
——-DO ANOTHER TEST——-
Finally, if you say the chance is 50 % 50 % then you must see some good news in the FDA briefing document.
Could you give us a quote from the FDA briefing document, or perhaps two, that you believe show good news ?
I really appreciate your comments and opinions and for this reason I’d like to know your opinion about the approval of the facility in Italy by the FDA.
I don’t think it was a small thing I’d rather think would be a very good signal.
Thank you and best regards
I would appreciate your take on the news today with this class action investigation please…