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Re: $heff post# 51997

Tuesday, 02/21/2012 2:04:51 PM

Tuesday, February 21, 2012 2:04:51 PM

Post# of 97237
Here is another bit of news that was probably overlooked today with their FDA news. People need to remember this is the drug that has been the major area of Focus IMO. This drug will be the only one of its kind on the market.


Another piece of good news today that was probably overlooked.


Clinical pipeline updates

* Enobosarm (Ostarine(TM), GTx-024), an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer: GTx was granted the generic name "enobosarm" for Ostarine as a first in class agent. GTx has recently commenced two pivotal Phase III clinical trials, POWER1 and POWER2 (Prevention and Treatment Of Muscle Wasting in CancER) in patients with advanced non-small cell lung cancer. These clinical trials were designed based on feedback from the United States Food and Drug Administration (FDA). In the fourth quarter, GTx met with representatives of the Medicines and Healthcare Products Regulatory Agency (United Kingdom) and Medical Products Agency (Sweden), who confirmed that the design of the POWER1 and POWER2 clinical trials should be sufficient for the European Medicines Agency to support registration in Europe

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