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发表于 24-8-2009 07:28 PM
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August 24, 2009 - Shares of Cell Therapeutics, Inc. (CTIC) are set to open up premarket at $1.80 in about an hour as the FDA has approved the application for pixantrone for standard review. Fast Track status will be ruled on by 9/4/09. If CTIC can get fast track status, there will be an FDA approval ruling in late December.
Cell Therapeutics, Inc. (CTIC) FDA Application News
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.
"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review," noted James Bianco, M.D., Chief Executive Officer of CTI.
About Pixantrone
Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although anthracyclines are sufficiently effective to be used as first-line (initial) treatment, anthracyclines cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if the patient's disease returns. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. The FDA is required to set an action date for review of an application 74 days after the initial submission of the NDA. CTI expects to receive the action date for this drug candidate from the FDA and a final decision on review status on September 4th, 2009. |
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发表于 25-8-2009 12:26 AM
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后劲不足，
| Last Trade: | 1.67 | | Trade Time: | 12:24pm ET | | Change: |  -0.02 (-1.18%) | | Bid: | 1.66 x 53,147 | | Ask: | 1.67 x 31,120 |
BidPriceSize1.6653,1471.6536,1001.6430,1001.6332,2191.6233,900AskPriceSize1.6731,1201.6834,3061.6933,7201.7026,8131.7123,581 |
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发表于 25-8-2009 12:49 AM
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发表于 25-8-2009 09:47 AM
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呵呵 昨晚應該賣了她後又買回。 
每次都是假動作。  |
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发表于 29-8-2009 09:48 AM
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有再好的news它都冲不上，都几个月了还在“FDA”，是不是2010年了都还在“FDA”？ |
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发表于 29-8-2009 11:37 AM
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发表于 31-8-2009 10:40 PM
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Cell Therapeutics, Inc.(RT-BATS: CTIC)
| Last Trade: | 1.61 | | Trade Time: | 10:39am ET | | Change: |  0.05 (3.21%) | | Bid: | 1.60 x 72704 | | Ask: | 1.61 x 49700 |
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发表于 31-8-2009 10:46 PM
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Cell Therapeutics, Inc.(RT-BATS: CTIC)
| Last Trade: | 1.69 | | Trade Time: | 10:45am ET | | Change: | 0.13 (8.33%) | | Bid: | 1.69 x 46811 | | Ask: | 1.70 x 50600 |
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发表于 4-9-2009 11:25 PM
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Cell Therapeutics, Inc.(RT-BATS: CTIC)
| Last Trade: | 1.27 | | Trade Time: | 11:25AM ET | | Change: |  0.26 (16.99%) | | Bid: | 1.26 x 9800 | | Ask: | 1.27 x 8600 |
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发表于 4-9-2009 11:34 PM
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不確定的消息....好像是FDA 细胞疗法（纳斯达克：纺织信息中心）今天说，美国食品药品管理局已否认
该制药商其优先审查的要求与试验
抗癌药物Pixantrone。
Pixantrone现在面临着一个标准的10个月的审查，而不是6
本月复审通常赋予一个优先审议 |
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发表于 5-9-2009 10:16 AM
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CTIC 的一部份股東給人耍了。。。
http://www.todaysfinancialnews.c ... quiet-day-9937.html
TFN eNews 09/04/2009: WTF CTIC! This was supposed to be a quiet day
Published via e-mail broadcast on September 4, 2009
In today’s TFN eNews:
* Cell Therapeutics (NASDAQ TIC) roller coaster
Dear TFN Reader,
There was some incredible action on Cell Therapeutics, Inc. (NASDAQTIC) today.
(The company develops and commercializes treatments for cancer.)
Laura Cadden had recommended this stock to Hot Stock Confidential members on August 20 in view of some upcoming FDA announcements. Thanks to the long weekend, I found myself minding the store today. Having received specific instructions not to take my eyes off CTIC this morning, I watched the stock gain 1.3%, 1.5% over yesterday’s close.
Then, suddenly, the shares fell off a cliff: 5 million shares dropped, erasing 20% of the stocks valuation in seconds. The only thing missing in the chart were cartoon lemmings falling off said cliff!
This was supposed to be a quiet day!
What had happened? There was no news out… only the Google message boards had an entry: “Cell Therapeutics (Nasdaq: CTIC) said today that the FDA has denied the drugmaker its request for a priority review of its experimental cancer drug Pixantrone. Pixantrone now faces a standard 10-month review, instead of the six-month review usually granted under a priority review. A priority review is often only granted to new treatments when no drugs are available for a particular illness. However, Pixantrone’s rivals may make it to the market before or around the time of the FDA action. CTIC expects a Pixantrone action date by the FDA in summer 201
Innocuous. Realistic. Plausible. Or so I thought until I saw the price increase just as steeply. Then it dawned on me.
Someone was having a little too much fun with the message boards! The message itself could’ve been a few days old… after all CTIC itself signed responsible for muddying the waters with some ambigious press releases in the past few days.
It may have been just the timing that triggered the exaggerated response! Among the hundreds of new threads on CTIC that suddenly sprung up, one caught my eye: “To All the Idiots that just sold their Shares”: Thank you very much—you are all gems. Got in big at $1.28.
The company itself moved like molasses: By 1:30PM, they had neither posted a rebuttal, new news — let alone returned my phone calls to their investor relations guru.
Here’s what Laura originally wrote back in August:
“Now what’s at stake here is not complete FDA approval of a drug, but instead the acceptance of priority review. If this is awarded, then the actual FDA approval decision date will be December 24. Pixantrone has already received FDA fast-track status for the treatment of relapsed or refractory aggressive non-Hodgkins’ Lymphoma (NHL). Patients treated with Pixantrone have a higher rate of confirmed and unconfirmed complete remissions compared to those who received standard chemotherapy treatments. The clinical uses of Pixantrone could include non-Hodgkins’ and Hodgkins’ lymphoma, acute leukemia, breast cancer, and multiple sclerosis.
“The potential profits if this drug goes to market could be more than $1 billion.
“This stock had a 52-week high of $3.20 but its potential is huge. Already yesterday, the stock rose 10% on expectations of success. This isn’t the only promising drug in CTI’s pipeline, but it is its gravy-train candidate right now. Just based on this one drug — if all goes well — we should be able to bank nice gains by the end of the year… perhaps even next week. I recommend you buy shares of Cell Therapeutics Inc. (NASDAQTIC) at or under $1.75 and hold on for 30% gains or more.”
For today, the company expected to receive the action date and a “final decision on review status”. At least, that’s what they had announced a few days ago. By 1:33PM, the share price was back to breakeven over the open price.
There are two lessons to be learned from this:
#1: Don’t believe everything you find posted on a message board… especially if it sounds plausible.
#2: Don’t apply automatic stop loss positions on speculative positions!
We remain in the stock and await a call back from the company! |
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发表于 5-9-2009 10:26 AM
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http://www.todaysfinancialnews.c ... -of-prank-9933.html
Sudden drop in Cell Therapeutics, Inc. (CTIC) result of prank?
Cancer drug maker Cell Therapeutics, Inc. (NASDAQTIC) saw its shares plummet today after a mysterious posting popped up on Google message boards. We were in for the ride!
by J. Christoph Amberger
Baltimore, MD — TFN: There was some incredible action on Cell Therapeutics, Inc. (NASDAQTIC) today.
.......... |
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发表于 5-9-2009 12:42 PM
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卡.............................. |
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发表于 5-9-2009 12:42 PM
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卡.................................2 |
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发表于 5-9-2009 12:43 PM
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卡.................................3 |
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发表于 5-9-2009 12:43 PM
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发表于 5-9-2009 03:04 PM
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没有消息就应该是没有priority了
等明年4月吧 |
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发表于 5-9-2009 04:21 PM
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发表于 7-9-2009 09:57 PM
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卡.................................10 |
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发表于 10-9-2009 08:57 AM
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Cell Therapeutics, Inc.(NasdaqCM: CTIC)
After Hours: 1.46 0.00 (0.00%) 7:58pm EThelp
Last Trade: 1.46
Trade Time: 4:00pm ET
Change: 0.02 (1.39%)
Prev Close: 1.44
Open: 1.50
Bid: 1.45 x 4000
Ask: 1.48 x 3200
1y Target Est: 50.00
Day's Range: 1.42 - 1.51
52wk Range: 0.05 - 2.23
Volume: 19,224,452
Avg Vol |
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