If you notice this is the same article I posted earlier (same page) but it now reflects "It is a phase II/III trial..."
Before it said "It is a phase II trial..."
The day I posted that, I wrote an email to the person at the bottom (Kim) to highlight what seemed like a mistake. Seems she made a correction although she did highlight a point which I share below.
=======>
I’m told its just a technical regulatory registration issue.
From: (removed)
Date: Thu, 2 Feb 2012 11:38:06 -0500
To: Kim Savage
Subject: Re: Error in your article
Hi Kim
Thanks for the explanation. It's still a little confusing as there is already a phase IIb in progress according to Prima.
Could you possibly share what are the concerns from the FDA ?
As an investor in Prima I'm be very interested to understand that. Nothing too serious I would hope.
Thanks and regards
(removed)
-------- Original message --------
Subject: Re: Error in your article
From: Kim Savage
To: (removed)
CC:
Thank you for your note. I double checked with our clinical research team and they shared the following:
“The study is listed in the U.S and on clinical trial.gov as a phase 2B. Globally (everywhere except U.S) it is considered a Phase 3. The FDA has some concerns that the sponsor has to address prior to allowing the sponsor to call it a phase 3 study. This is why it is different in the US than in other places.”
I welcome your feedback if you still believe our statements are erroneous.
Thank you,
Kim Savage
Sr. Communications Editor
Sarasota Memorial Health Care System
1700 S. Tamiami Trail, Sarasota, FL 34239
(941) 917-6271 / (941) 893-7649 cell
From: (removed)
Date: Thu, 2 Feb 2012 03:15:28 -0500
To: Kim Savage
Subject: Error in your article
Please see the below message entered in the contact form on PR.com for your press release.
Press Release URL: http://www.pr.com/press-release/387492
Press Release: Experimental Ovarian Cancer Vaccine Offers Hope for Cancer Patients
From: (removed)
Email: (removed)
Phone #: (removed)
Date: February 02, 2012 - 3:15 AM EST
Message:
Hello Kim
Just writing to say that I just read your new article about Prima Biomed's CVAC. You mention that the trial is a phase II trial. It's not. It's phase III. Phase II (IIb to be accurate) is fully recruited (60 patients). Could you possibly make a correction to the article page directly ? ... or perhaps send out a correction note.
Regards
(removed)
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