Epanova | AMRN Message Board Posts

Amarin Corporation plc

  AMRN website

AMRN   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  4413 of 6915  at  6/20/2019 11:49:13 AM  by

sphericalkutz


 In response to msg 4412 by  ex_hacker202
view thread

Re: Epanova

 Hacker:  I got the jest of what you were trying to say.  Long term studies can lead to a lot of amendments but that does not mean consent has to be re-done every time.  Its dependent on the amendment content.  
 
If talking to the FDA leads to an amendment to say alter the statistical package, then that is not going to stimulate a change to the informed consent as that has no bearing on the conductance of the study specifically for the patient.  But the site investigator would still have to go thru their IRB approval process.  These outcome trials lead to many changes along the way simply because of their mass and the extended timeline---they suck to manage!  The databases are just enormous!
 
JMO Epanova is junk!  AMRN is sitting in the catbird seat post Reduce-It.  Just going to need to stay patient!
 
Disclosure:  Been adding several times to a an old cheap core held long under 20.00.  Some of old shares sold at results.  I have a nice pile now, but I don't think I am keeping up with Sharon though---LOL!  I own too many bios--I spread the money around.
 
Just waiting around for the sNDA decision!  Its not that far away.
 
JMO
 
kutz 


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 0     Views: 168
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board






About Us  •  Contact Us  •  Follow Us on Twitter  •  Members Directory  •  Help Center  •  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
© 2003-2019 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...