TOP 100 MEDICAL SITES
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| Nanosphere, Inc. Q1 2010 Earnings Call Transcript Nanosphere, Inc. (NSPH)Q1 2010 Earnings CallMay 6, 2010 11:00 am ETComplete Story » seekingalpha.com |
Antibody Kills 91% of HIV Strains In a significant step toward an AIDS vaccine, U.S. government scientists have discovered three powerful antibodies, the strongest of which neutralizes 91% of HIV strains, more than any AIDS antibody yet discovered. online.wsj.com |
Americans Cut Back on Doctor Visits Insured Americans are using fewer medical services, raising questions about whether patients are consuming less care as they pick up more of the cost. online.wsj.com |
FDA Reviewing Safety Information on Actos The Food and Drug Administration said Friday it has started a safety review of Takeda Pharmaceutical Co.'s diabetes drug Actos, looking at links to bladder cancer. online.wsj.com |
Risks vs. Benefits in Holding Alexza Through Approval of AZ-004 Sheff Station submits:The important thing in weighing whether to hold a stock through FDA approval or not is to determine what the potential of the stock is after approval. That should be done with every potential approval I have assessed in 2010 as I have been very accurate in my assessment of FDA approvals this year. My toughest scrutiny with a company comes 5-10 days before an approval because I have all of the investment conference notes and clinical data in front of me in order to accurately assess at one time rather than in pieces. With some companies an FDA approval does not necessarily mean a boon to the stock price. That is why this assessment focuses more on the price after approval. RBC has a conservative estimate of $5 post approval and JPM Securities has a more aggressive estimate of $12 post approval of ALXA upon an approval for AZ-004. No one ever knows what the FDA is going to do even if a company has a panel meeting and potential issues have been addressed and seem apparent. It seems that the AZ-004 data has been clear and transparent in terms of efficacy and safety from the beginning of their Phase II clinical trials with no need for an FDA panel prior to approval. I think the lack of FDA panel is a moot point and can’t be viewed as either a positive or negative by the investor in this specific case. AZ-004 is having their first go around with the FDA today, Oct. 11th. They have not had an approvable letter, complete response letter, or any delay with regards to their product. An investor does not know what the FDA is looking for when they ponder the approval of a drug; that will be the first time a CNS drug is being delivered directly into the lung.Complete Story » seekingalpha.com |