Aug. 20, 2010 (Baystreet.ca) --
The call volume on this Nasdaq listed biotech stock is way up- with about 14x the average daily volume of 15. As you know, high call volume is an indicator that many investors are looking for higher prices in the near future and that certainly applies to shares of Chelsea Therapuetics Inc (NASDAQ: CHTP), which have been been drifting higher over the past nine trading days gaining over 20% (Note also the newly formed Golden Cross on the stock chart). The run comes off news that the FDA is poised to pull ProAmitine (Midodrine) from the market due to Shire (SHPGY) not conducting post-approval studies to prove that the drug has a benefit. Shire confirmed they have elected to withdraw the product effective September 30, 2010.
The withdrawal of Shire’s drug would also stop all sales of any generic version. These generic companies include Mylan Pharmaceuticals (MYL), Impax Laboratories (IPXL), and Novartis (NVS) unit Sandoz, must stop selling their generic versions of Midodrine. About 100,000 U.S. patients filled prescriptions for brand or generic forms of ProAmatine in 2009, the FDA said. Why does this matter to CHTP? With all of the competition removed, CHTP’s lead drug, Northera, will have a substantially larger market to fill, if approved. Some analysts have projected the market size for their drug to be around $200-300M.
Investors are anxiously awaiting news from CHTP’s pivotal Phase 3 trial with results due in September for their lead drug, Northera (droxidopa), for the treatment of orthostatic hypotension. Study 301 was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA) in February 2008. The FDA subsequently confirmed that the SPA remained in effect following the protocol amendments approved by the FDA late last year, after their Study 302 did not meet the primary endpoint, yet did very well in other endpoints. [Patrick Crutcher covers the healthcare sector for BioMedReports]
