Reltr is nothing but a paid basher and a liar,you should ask Mr Liar why EMEA hasn't required any additional studies, they have passaed that milestone in the process.
And aks him why top biotech analysts in Sweden with a very good insight in EMEA has said 85%-90% probability of approval.
Listen to the oncology cc also, Jack reiterates the CALGB study as done and submitted and showing no IL@ alone efficacy:
Don't be fooled by the bashers BS, read and listen for yourself and make up you OWN MIND
This is from my boy synergy, sorry for the last post!
Message board scientists and non-scientists,
�your links are still, not linkaBle,
and another thing:
why then PatZZZdur_FDA, (as it was communicated by Maxim at the end of 2005), insisted on additional phase-3 trial. It looked, though, that there were no patZZZ_questions related to (Ceplene+IL2) versus (IL-2 alone) effectiveness, but rather the sufficiency of 1 study for FDA approvability ???!!!! :
�Maxim Reports That Additional Phase 3 Trial of Ceplene Therapy in the Treatment of Acute Myeloid Leukemia Patients in Complete Remission Will Be Required by the FDA
Business Wire, Jan 18, 2005
SAN DIEGO -- Company Continuing Discussions with European Regulators Regarding AML Application
Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM)(SSE:MAXM) today announced that based on ongoing correspondence with the United States Food and Drug Administration (FDA), as well as consultations with external advisors, an additional Phase 3 clinical trial will be necessary to further evaluate Ceplene plus Interleukin-2 (IL-2) combination therapy for the treatment of acute myeloid leukemia (AML) patients in complete remission before applying for regulatory approval in the United States. In May 2004 Maxim announced that its Phase 3 clinical trial studying Ceplene plus IL-2 therapy in 320 AML patients in complete remission met its primary endpoint, improvement in leukemia-free survival. Maxim will continue discussions with the FDA regarding trial design, however, given the time and costs required to conduct another Phase 3 clinical trial, the Company believes that such trial would need to be done in collaboration with a corporate partner, and Maxim intends to pursue partnering opportunities in the United States related to Ceplene for the treatment of AML. Maxim is continuing discussions with European Regulators to determine if an additional Phase 3 clinical trial is necessary for European regulatory approval. The Company will continue to evaluate strategic options related to the above outcomes. �
From GNTA pond, and the admirer of biGGG scientificAL Daddy
And further more...look at what the analysts say about azixa over at mygn! I really don't know how smart you are, and I am sure you are (being very serious) but why is the rest of the world so excited about azixa and you are luke warm? you are the only one saying its not going to be a blockbuster...mygn is a $1B company! If you know so well, then why are the analysts pretty much showing an approval BASED ON THE CLINICAL TRIALS RUNNING CURRENTLY! Plus are you forgetting lidopain, AND the further VDA pipeline...
for a promising biotech stock, you seem very negative...when IMMU is in the exact same boat as this. you want more promising biotechs with nothing to offer?
all of those have nothing to offer and have a market cap of almost 2X! and why did this hit $4.50?
No no reltr, The chicago paper held up significantly to show that the effect of IL-2 was NOT APPLICABLE. this was a statistically significant trial, and it showed the effect of IL-2, plain and simple as nothing. As far as dosing and time lengths will be shown as irrelevant...once they accepted the fact that ceplene improved life and met ALL OF ITS PRIMARY ENDPOINTS. Please explain how the chicago trial doesn't fulfill any of the questions about IL-2 alone when they were explicitly asked for a trial showing the effects of IL-2 alone by the fda, they did the trial, and it showed no help?
thanks...I am not a scientist, please explain to us commoners...
I have a very serious question that I would love you to answer honestly...why are you here bashing every day? You cannot short a sub $5 stock and you are a scientist! why aren't you using your expertise and brilliance to MAKE money in the market, rather than saving ME some money? please answer honestly, because something to me doesn't add up!
For the last time the endpoints are fine. Absolutely fine. No one is arguing that the endpoints aren't acceptable.
What your meager brain isn't understanding is that IL-2 + Ceplene had an effect. But there is absolutely zero ZERO NONE ZERO NONE data showing that the effect didn't come from the IL-2 cotreatment.
Don't throw the Chicago study back at me as it is not supportive because the dosing of IL-2 in AML patients was over a much shorter time and given differently than in the Maxim study.
YADA_YADA _YADA - you are a scientist - pull the Chicago paper and read it carefully. You'll see what I'm talking about. I'm a scientist too. Here me out and at least give the paper a good read and give me your rationale to be in EPCT. Also - read the package insert on IL-2. It is OK'd for melanoma, but not AML. The Maxim dosing in patients resulted in tossing 22/23 of the material as it was a low dose study. If you need help converting Units of IL-2 to mg/m^2, let me know and I'll help walk you through it.
As for Azixa, milestone money for the phase II are a months burn. VDAs have been around forever. Combretastatin has been in trials for ten years with no luck. Don't hold your breath. IF Ceplene fails and it likely will - this stock will be in real trouble. That is why there is no major Pharma partner and no efort by EPCT to put a sales force in place. The management there has taken the same approach as Melesto12 - praying for a miracle. Drug approval as is science is based on fact. NO facts showing IL-2 wasn't responsible for the positive results of the study.
You haven't done your homework shorter, why did EMEA accept the phase III studies primary endpoints in february this year, shorter you should stick to facts or does the truth scare you shorter?
You should read what they are saying here in Europe about Ceplene, I wonder why topbiotech analysts in Europe with a very good insight in EMEA are saying Ceplene 90% probability of approval, why do you think the institutionals are holding their stocks, I mean come on shorter people are laughing about the volume on the dips.
The longs are the winners in this stock :-)
Ignore this idiot. Ask this simple question:
140 doses of IL-2 were required for efficacy. $each dose is ~ %3000. ~ $5OO,OOO FOR IL-2 alone. Not to mention Ceplene has an effect - no control arm.
To extend life several months. No way man is a medically limited gov't in EU going to pay for that. The FDA said forget it. Best regulatory agency in the world said no. No, No, No. Sinking ship.
Oh yes paid basher, paid basher. Whatever, Check out the phase 111 trial data and do the math.
Pathetic, believe me I live so close to the Lord I know evil when it appears. You are not making any money on the internet unless you are a paid basher. If you are such a great person and so happy shy are you here attacking and bashing everyday we are down, when we are up you are long gone.