"The U.S. Food and Drug Administration said on July 10 that the sNDA expanding Relistor's indication to include chronic non-cancer pain patients with OIC can be approved on the data previously submitted in that filing. The decision follows Salix's appeal of the agency's Complete Response Letter on the filing two years ago and an Advisory Committee convened by the FDA last month. Salix submitted to the agency on July 25 information required for final approval, and we expect a two-month review.
Salix has said it intends to meet with the FDA as soon as possible to discuss a path forward for oral Relistor for the treatment of OIC in patients with chronic, non-cancer pain.
Results from two trials of the Company's small molecule PSMA imaging agent for prostate cancer, 1404, are scheduled to be presented at a featured oral session during the annual meeting of the European Association of Nuclear Medicine (EANM) in Gothenburg, Sweden on in October.
The phase 2 complete study results involving 104 patients are to be presented by Dr. Gabriella Dabasi of Semmelweis University.
Dr. Shankar Vallabhajosula of Cornell University's Medical College is to present phase 1 pilot study results on nine patients."
Ignorant heard mentality, confusion, or what?
5:01 pm Salix Pharma to combine with Cosmo Technologies; transaction expected to be modestly accretive to EPS in 2016 (stock halted) (SLXP) : Co and Cosmo Pharmaceuticals announced a definitive merger agreement under which Salix will combine with Cosmo Technologies Limited, a subsidiary of Cosmo. Under the terms of the agreement, Salix will become a wholly-owned subsidiary of Irish domiciled Cosmo Tech, which will change its name to Salix Pharmaceuticals, plc and is expected to have its ordinary shares listed and traded on the NASDAQ Global Select Market. The transaction is expected to be modestly accretive to Salix's earnings per share in 2016 and increasingly accretive thereafter.
Salix Pharmaceuticals, plc will own Cosmo's U.S. patents for rifamycin MMX, methylene blue MMX and Uceris, and have specified rights of negotiation with respect to all products Cosmo or its affiliates seek to develop or commercialize in the U.S. In addition, Salix Pharmaceuticals, plc will acquire Cosmo's patents for rifamycin MMX in Canada, specified Latin American countries, India, China, Japan and the rest of the Far East, excluding Australia and New Zealand, and Cosmo's patents for Uceris in Japan.
Upon completion of the merger, shareholders of Salix are expected to own slightly less than 80% of the ordinary shares of Salix Pharmaceuticals, plc and Cosmo is expected to own slightly more than 20%. Shareholders of Salix will receive one ordinary share of Salix Pharmaceuticals, plc in exchange for each share of Salix Pharmaceuticals, Ltd common stock they own at closing. In connection with the merger, Cosmo will continue to supply Uceris to Salix and will also supply rifamycin MMX and methylene blue MMX. Additionally, Cosmo will have the right to designate one director to serve on the board of directors of Salix Pharmaceuticals, plc and will be subject to certain standstill provisions for at least 10 years following the completion of the merger. The transaction, which will be taxable to Salix's shareholders, is expected to close in the fourth quarter of 2014.
In connection with the transaction, Salix will also receive certain rights and protections under a Right of Negotiation and Non-Compete Agreement, which will: (1) give Salix a right of first negotiation with respect to all future products Cosmo or its affiliates seek to market in the U.S. in the GI space, and (2) prohibit Cosmo from competing directly with the combined company in the GI space in the U.S. These terms will apply as long as Cosmo is entitled to designate a director to serve on the board of directors of Salix Pharmaceuticals, plc.
$PGNX director, Crowley Peter J bought 55,000 shares @ $4.47 on 06/17. SEE EDGAR for details
Closed above the 200 Day Exponential Moving Average also . Huge gap at 5.28, so if we can get over that it would be super bullish.
Transocean can see the value that Seadrill Partners has created for investors in Seadrill. It wants that same value to accrue to its investors, which is why it is copying Seadrill and creating its own MLP. This will enhance Transocean's financial flexibility by allowing it to monetize some of its rigs while still profiting from retaining an ownership interest in those assets.
New write up at Value Investors Club. Author' last 5 picks have averaged 54% . Progenics offers an (cont) ...
By the close, interesting day
I like the Exponential Moving Averages(EMA) because they are faster moving, more ahead of the crowd so to speak.
We are closing above the 200 Day Exp Moving Average (4.37) for the first time today! Bullish now.
quote from PR "In the formal vote, twelve (12) Advisory Committee members voted to not require cardiovascular outcomes trials (CVOTs) for PAMORAS being developed for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. Seven (7) members voted to require CVOTs for all PAMORAS, and five (5) members voted to require CVOTs, but only for specific PAMORAS. In the post vote discussion, five members stated they misunderstood the question and would have voted to not require CVOTs. Specifically, the Committee recommended that observational studies be conducted on a post-marketing basis."