Thus spoke the Professor, page-12

Low Back Pain: Received written guidance from the FDA that based on the composite primary endpoint that was already met, Mesoblast's product is acceptable for product approval. Meso will update the market in due course.

Really?

Based on the primary endpoint that was already met, the product is acceptable for product approval?

The CEO actually said that?

WOW!
That is absolutely HUGE news.

They should therefore go through the formalities of gaining approval and start start selling the product straight away.

I wonder when they received that written advice from the FDA?

And more importantly, why they didn't announce it to the market, as opposed to mentioning it as part of a general investor presentation, because that is a highly significant development which is certainly highly price sensitive.

(Unless, of course, Yankee is misquoting what the CEO said... if so, it would be a slip up along the same magnitude as him/her deeming Teva to still be on board as a MSB partner in June last year because someone answered the phone at a recruiting centre when Yankee called.)