Seeking Alpha

Mike Havrilla's  Instablog

Mike Havrilla is an index developer, pharmacist, writer, and Co-Founder of BioMedReports.com with experience that includes online investing since August 1997 and writing for investors since April 2007 with a focus on the healthcare sector and small / micro-cap stocks. Mike holds Doctor of... More
My business:
ProActive HavRx BioFund
My blog:
BioMedReports.com FDA Calendar
My book:
ProActive HavRx Stock Indexes
  • FDA Calendar Updates: COV, CRXX 0 comments
    Jul 4, 2009 02:48 PM | about stocks: COV, CRXX

    Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

     
    On 7/1/09, CombinatoRx (NASDAQ:CRXX) and Neuromed Pharma (privately held) announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed’s New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone).
     
    The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date of 11/22/09 for a possible FDA decision.
     
    Disclosure: No positions.
    Stocks: COV, CRXX
Back To Mike Havrilla's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Full index of posts »
Latest Followers

StockTalks

  • $MNTR.PK / Healthcare IPO Stocks for 2010: Quantum Immunologics (QI), Epinex Diagnostics / News Room websites at http://bit.ly/8i3mMN/
    about 1 hour ago
  • $ANIK / Anika Therapeutics acquires bio-polymer, regenerative medicine company / Expects FDA decision 2H10 for Monovisc injection
    about 3 hours ago
  • $CSIQ / Canadian Solar $5 (Nov. 2008) to $28.77 today / http://seekingalpha.com/a/29sh / ProActive Clean-Tech Index at http://bit.ly/76BhUH
    about 17 hours ago
More »
Posts by Ticker
AAPL, ABII, ABIO, ABT, ABV, ACAD, ACCP.OB, ACOR, ACUR, ACUS, ADAM, ADLS, AET, AEZS, AFFY, AGEN, AGN, ALKS, ALNY, ALPMF.PK, ALTH, ALXA, AMAG, AMGN, AMLN, AMRN, ANPI, APPA, APPY, ARDM.OB, ARKTF.PK, ARNA, ARUXF.PK, ARYX, ATHN, AUXL, AVNR, AZN, BAX, BAYRY.PK, BCRX, BDSI, BFRM, BIIB, BIOD, BMRN, BMTI, BMY, BPAX, BSX,

Latest Comments


Most Commented
  1. BioMedReports.com Mention in BusinessWeek (7 Comments)
  2. Sequenom Splattered, EXACT Sciences on the Rise (3 Comments)
  3. Who Will Take GM's Place in the Dow? (3 Comments)
  4. 13 Extreme FDA Trades: BioMedReports.com 6/1/09 Update (3 Comments)
  5. Mentor Capital: A Stealth Cancer Immunotherapy Play (3 Comments)
Posts by Themes
allos therapeutics, ANDA, ASCO, Avastin, BIO.PA, BioAlliance, biogenerics, biomed, BioMedReports.com, biotech, BLA, Botox, cancer, cancer biotech, cancer stock, China, cholesterol, Clean Energy, Clinical Trial, Clinical Trial Calendar, Clinical Trials, clinical trials, consumer staples, Crestor, DAVANAT, defensive, Dendreon, Diabetes, Discovery Labs, dividends, Dolphin Secure, Dysport, Enablex, ETF Innovators, Extreme Trades, Facebook, FDA, fda, FDA Calendar, Feraheme, Genentech, generic, Generic Drugs, Global Pharma, GTx, Health IT, Health IT Index, healthcare, Impax Labs, Impax Pharma,
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.