It's a phase III if ever there was one. Following what you will...

It's a phase III if ever there was one. Following what you will read below, I also triple checked this with MR to ensure that the FDA definitely DO consider the CANVAS trial as a phase 3.

I posted this article a while back (2nd Feb)...

http://hotcopper.com.au/post_single.asp?fid=1&tid=1660200&msgid=9570181

(which if you look is the same article link as boiler posted, but at the time I posted it, it stated that it was a phase II trial).

Hence, I followed up with this post ...

http://hotcopper.com.au/post_single.asp?fid=1&tid=1660200&msgid=9570200

Then I had a mail with the author of the article ...


[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 #: +6581580119
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
xxxx



-------- 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 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
xxxx


Begin forwarded message:

I’m told its just a technical regulatory registration issue.]