timelinefor cvac taken from southern equity, page-6

Different regions in the world require different bodies to approve drugs/technologies. Since CVac is a blood product (from the patient) in some places it can go to market without FDA approval.

Some of you may know that Mesoblast did a similar thing when the TGA approved their products meaning they can go to market in Australia without needing FDA approval.

There are obviously requirements, main one being proven safety.
Hence why proving safety for products like CVac can be a critical part to getting into the market. With that said most cancer drugs available now clearly show some serious side effects. Take the market leader Avastin (bevacizumab)...sales of $6-8billion annually yet

http://topnews.ae/content/27943-no-truce-between-fda-and-genentech-yet-over-use-avastin

http://www.nytimes.com/2011/06/27/health/27drug.html


And one from the Wall St journal:
http://online.wsj.com/article/SB10001424052702304259304576373902643334930.html
"Avastin doesn't work very well and has significant side effects."


Whether CVac passes Phase 3 is anyones guess, either way cancer vaccines is where it's at. It's early stages in the field and first in best dressed is the way to go until technologies get better. With that said there is room for plenty for competition in the market that is worth countless billions every year and growing exponentially with world population growth and people's life expectancy growing. ie If there where 5 vaccines for Ovarian Cancer alone, you'd imagine that all could still make nice profits. Which one performs best in clinic and is safest likely to get the larger market share (logically speaking).
That's why early market approval would be big if it when ahead for CVac and Dubai deal was a beauty.

Also with designing a Phase 3 trial for Breast Cancer later in the year it opens the breath of market up.

Anyways...let's just kick back and wait for the announcements (sips beer).