Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(R) In Colorectal Cancer
Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 06 Jan 2011 - 1:00 PST
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.
"If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals. Continued
Showing posts with label Colorectal cancer. Show all posts
Showing posts with label Colorectal cancer. Show all posts
10/28/10
Exact Sciences Announces Positive Results For Cancer Diagnostics Screening
Exact Sciences is experiencing a wild After-Hours Ride Today. It has dropped significantly below 6.50 then back up to 8.57 and now back down to 6.75. I wonder about a flash crash happening in after hours trading and how much investors are selling off their stocks. Right now Exact is down 1.83 at 6.74 a 21% loss. But it will be right back up tomorrow so I'm not sure what is really going on. Massive afterhours sell-off is causing a crash. Take a look at afterhours trading news here at Marketwatch: EXAS
Now is not a time to sell as trading Friday could be significant gains with news of a successful Diagnostic testing for Colon Cancer screening. But what is going on with Investment Banks right now in after hours trading is somewhat troubling. How much is controled in after hours trading is a mystery to me, but I know it is not the average investor making these moves. Internal trades are happening at this moment but why is the price of Exact Sciences dropping so much. Trading was halted earlier today in anticipation of the news release. Here is that news.
Exact Sciences says colon cancer test successful
* Screening test detects 64 pct pre-cancers
* Detects 85 pct cancers
* Exact Sciences test detects 87 percent of tumors
* Finds 64 percent of pre-cancerous growths (Adds details on 2nd test, refiles to fix headline)
10/17/10
Exact Sciences Anticipating Oct. 29th Results
Image by Christiana Care via Flickr Exact Sciences has been on fire lately. I do think that the stock will dilute in the next few weeks but I could be wrong. They will need to recoup some of their capital from their clinical trials debt that they have accrued. Exact Sciences is a very explosive stock that could really go higher than expected. Who Knows? I really like the options for Exact Sciences growth in 2011 and beyond. In 3 Months Exact has gone from 3.46 to 8.88, a gain of 158.89%. I expect it to drop down a bit and would suggest any future purchase of shares to come down a bit with a Limit Order. Buy Exact at some form discount at these very hyped up increased levels. But they might not come down and you should buy some at the current Market Price. Wikinvest---Exact Sciences (EXAS)
Google Finance--Exact Sciences (EXAS)
Biotech Stock Mailbag: Exact Sciences
BOSTON (TheStreet) -- Did you catch Jim Cramer's excellent Mad Money segment Wednesday on Exact Sciences(EXAS_)?
If not, a question from Paul P. on the colon cancer diagnostic stock kicks off this week's Biotech Stock Mailbag: "Have you followed and/or have any thoughts on Exact Sciences? I've been following it and am hearing that it may be overhyped. Your thoughts would be appreciated."
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