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TKPHY Analysis & Videos »


TKPHY: Bull or Bear?

Upcoming FDA Advisory Panel Meetings Graphic_rating_sell TKPHY
Mikerun
73%
 +100.00%
in 112 days
(closed on 06/29/09)

A trio of diabetes drug candidates are affected by a tougher stance at the FDA for this class of drugs, which is focused on cardiovascular risks such as heart attack and stroke. Two of the drugs will be reviewed at early April FDA advisory panel meeting while a third will likely require additional clinical trials.

http://www.biomedreports.com/fda-calendar.html

<> In December the FDA issued a new guidance document that recommended more stringent clinical trials for diabetes drugs to better assess heart attack and stroke risks. In a change that was effective immediately,...
By  Mike Havrilla   (+1.04%  risk: conservative)  03/09/09 Comment


Updated Clinical Trial and FDA Decision Calendars Graphic_rating_sell TKPHY
Mikerun
73%
 +26.95%
in 15 days
(closed on 03/09/09)
Updated FDA and Clinical Trial Calendars
 
By Mike Havrilla on 2/22/09
BioMedReports.com
 
Below is a summary of updates to the FDA decision calendar since my last article, which includes a total of 90 entries through today:
 
1.) Nuvo Research (NRIFF.PK) (Canada: NRI.TO) NDA re-submission for Pennsaid - A topical NSAID for arthritis pain/inflammation - along with Paladin Labs (Canada: PLB.TO)
 
<> 2.) Hemispherx Biopharma (HEB) Ampligen (Poly I: Poly C12U) NDA (three month PDUFA date delay announced 2/18/09 as additional data was submitted w...
By  Mike Havrilla   (+1.04%  risk: conservative)  02/22/09 Comment


A 130/30 Pharma Trade Graphic_rating_sell TKPHY
Mikerun
73%
 -0.10%
in 2 days
(closed on 02/22/09)
By Mike Havrilla on 2/20/09
ETF Innovators
 
The tables at my website link below include 12 U.S. listed companies from the ETF Innovators Global Generic Drug Index along with seven brand drug companies, which are ranked in descending order based on their patent expiration exposure through the end of 2011 as a percentage of total trailing 12-month revenue.
 
 
<> Investors who are bullish on the generic drug industry may consider implementing a 130/30 pharma trade by shorting any/all...
By  Mike Havrilla   (+1.04%  risk: conservative)  02/20/09 Comment


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Calendar of 163 FDA Decisions and Clinical Trials Graphic_rating_buy TKPHY
Mikerun
73%
 -13.78%
in 30 days
(closed on 02/20/09)
The tables at my web link below include an updated calendar of 80 expected FDA new product decisions and 83 pending clinical trial result estimates + pending FDA re-submissions. Click here for a link to my previous FDA calendars and the below is a summary of new entries and updates on the calendars.
 
 
<> 1.) Genentech (DNA) expects to report results in mid-April in its Avastin colon cancer adjuvant trial, in addition to pending FDA decisions to expand product labels for Avastin in relaps...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/21/09 Comment





People Bullish on TKPHY

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the_flux
Analyst
55%
about 1 year ago


People Bearish on TKPHY

Mikerun
Mike Havrilla
Principal
73%
4 mos ago

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