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MELA Analysis & Videos »
MELA: Bull or Bear?
FDA Calendar Updates: MELA, PGNX, VPHM, WYE
MELA
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+19.52%
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99 days
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 288 entries as of 8/5/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage cli...
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New Indexes to Track Healthcare Trends and More
MELA
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-3.00%
in
19 hours
(closed on 08/05/09)
Below are links and descriptions for 23 new stock indexes I have created, revised, and tracked over the past few years which are now featured at a new website called Investars YOU. The new site includes automated index tracking, allows investors to create custom stock portfolios based on their individual preferences, and now features free access to all of the component stocks in each of my indexes. Some of the top performing stocks from my healthcare indexes on a year-to-date basis are highlighted below.
Cosmetic & Restorative Medicine Index: Allergan (NYSE:AGN) (+38%) <> The <> ...
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FDA Calendar Updates: ABT, AFFY, AZN, LLY, MELA, PFE, VPHM
MELA
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-8.37%
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17 days
(closed on 06/21/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of about 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 <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following additional 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 pen...
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FDA, Clinical Trial Calendar Updates: AZN, IMGN, MIPI, MELA
MELA
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-0.48%
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24 days
(closed on 06/04/09)
<> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA fo...
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New Index of Cancer Diagnostic and Therapeutic Stocks
MELA
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+40.00%
in
29 days
(closed on 05/11/09)
By Mike Havrilla on 4/12/09 at BioMedReports.com The table at the link below includes statistics for the 40 companies in the ETF Innovators Emerging Cancer Diagnostic and Therapeutic Stock Index, which is featured at BioMedReports.com in the health indexes section of the site. The index will track the performance of stocks with market caps below $200M at the inception date of 4/12/09 from a starting value of 2,632. <> A World Health Organization report released last year es...
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Electro-Optical Sciences: Corporate Presentation Summary
MELA
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+49.25%
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20 days
(closed on 04/12/09)
Since I last wrote about Electro-Optical Sciences (MELA) positive results for MelaFind as a new diagnostic screening device for melanoma, the Company presented at the Cowen and Company Healthcare conference. Below is a summary of the presentation, including the razor/razor blade business model and targeted commercialization plans on a regional basis for MelaFind. <> The pivotal Phase 3 trial for MelaFind achieved statistically significant results for the pre-specified clinical outcomes ...
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Electro-Optical Sciences: Enabling Early Melanoma Detection
MELA
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-9.66%
in
7 days
(closed on 03/23/09)
MELA recently announced positive topline results in a pivotal clinical trial for MelaFind, which was conducted at seven medical centers across the U.S. and included nearly 1,400 patients and over 1,800 pigmented skin lesions. A larger study will also be conducted for MelaFind, with the results planned for submission to the FDA. Emerging Diagnostics Index: http://biomedreports.com/health-indexes.html <> <> The Company is currently preparing to file a PMA (with a six-month priority review designation and advisory panel meeting expected) for medical device marketing approval fro...
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New Preventive Medicine Index
MELA
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+5.95%
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50 days
(closed on 03/16/09)
One of the major reasons behind Pfizer's (PFE) interest in acquiring Wyeth (WYE) is the latter's focus on products outside of traditional pharmaceuticals – with 60% of Wyeth's revenue from last year derived from biological therapeutics and vaccines. It remains to be seen what happens to Wyeth's proposed deal to acquire Dutch vaccine maker Crucell (CRXL); however since it is much smaller (around $1B) and focuses on the development of vaccines, Pfizer would likely be interested in both companies together. <> With the focus on preven...
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Create Your Own Diagnostics ETF
MELA
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+0.00%
in
5 days
(closed on 01/25/09)
Create Your Own Diagnostics ETF <> With HealthShares closing shop at year-end , including the former Diagnostics fund, investors who are interested in the space can create their own ETF comprised of companies from the ETF Innovators Preventive Medicine and Emerging Diagnostics Indexes. Below is a list of companies which have stocks listed for trading in the U.S. at over $1/share with a market cap of less than $10B, focusing on smaller companies which are more leveraged to diagnostics and represent possible takeover targets for larger players such as Roche (...
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20 Emerging Healthcare Stocks to Watch in '09
MELA
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-0.47%
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10 days
(closed on 01/20/09)
<> As a follow-up to my most recent article on the buyout binge among bio-pharma and diagnostic companies, below is a basket of 20 stocks (listed randomly) to consider from the ETF Innovators Indexes of 250 companies which represent a mix of pending catalysts in the form of clinical trials or FDA decisions, innovative patent portfolios or drug discovery technology platforms, promising compounds in clinical development, and marketed therapeutic or diagnostic products. Click on any of the company names for links to all of my prev...
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Buyout Binge Begins for Bio-Pharma, Diagnostics
MELA
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+0.00%
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8 hours
(closed on 01/10/09)
<> 
<>
<> With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic space.
Larger and well funded bio-pharma and diagnostic companies are opportunistically looking to expand their product offerings, pipeline prospects, patent portfolios, ...
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Healthcare Catalyst Stocks for 1H09
MELA
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-2.54%
in
3 days
(closed on 01/10/09)
<> Below are four companies I have not written about recently with expected catalysts in the first half of 2009 in the form of FDA decisions or clinical trial results.
FDA Calendar of New Product Decisions
Last Fall, Discovery Labs (DSCO) received word from the FDA that its complete response for Surfaxin was accepted, but the six-month Class II review designation means that the decision date is pushed out to mid-April. DSCO presents a model trade on a pending FDA decision at this time since it will likely enjoy a run-up in ...
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About ElectroOptical Sciences Inc
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