PDUFA Date 15 July .MCap 21 M$= Big Bounce
Rally already begins ..Target 3$ soon !!!!!!!!
Approval will be huge for ARDM.OB .Big bounce is coming
ARDM.OB
Marketcap 21 Mio $
Cash 19,8 Mio $
Price 0,14 $
The FDA accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009.
In August 2006, we sold all of our assets related to the Intraject needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to Zogenix, Inc., a private company. Zogenix is responsible for further development and commercialization efforts of Intraject (now rebranded under the name DoseProtm). We received a $4.0 million initial payment from Zogenix, and we will be entitled to a milestone payment upon initial commercialization, and royalty payments upon any commercialization of products in the U.S. and other countries, including the European Union, that may be developed and sold using the DosePro technology. In December 2007, Zogenix submitted a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for the migraine drug sumatriptan using the needle-free injector DosePro ("Sumaveltm DosePro"). The NDA was accepted for filing by the FDA in March 2008. The same month, Zogenix entered into a license agreement to grant exclusive rights in the European Union to Desitin Pharmaceuticals, GmbH to develop and commercialize Sumavel DosePro in the European Union. On October 31, 2008, Zogenix received a Complete Response Letter from the FDA on its NDA. On February 18, 2009, Zogenix disclosed that the Complete Response letter from the FDA cited the need for a single additional in vitro test to be conducted and that Zogenix recently submitted the requested information to the FDA. The FDA accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009. Zogenix stated that it is their intention to launch Sumavel DosePro following FDA approval in the second half of 2009.
We recommend investors to take advantage of the current price weakness to purchase ARDM. At a market cap of $11 million and $22 million in cash as of February 2009, we do not believe the value for Aradigm’s pipeline including ILC or the inhaled Remodulin partnership is at all reflected in the current valuation. We strongly reiterate our BUY rating. The reduction of our price target to $3.30 from $6.00 is largely a function of the significant increase in the number of shares outstanding to 95 million from 54 million as a result of the recent 40 million share financing which was priced at $0.10 per share. Our price target is based on a 25x multiple of our 2012 fully-diluted EPS of $0.28 discounted back at 35% (see Table 2 below for details).
