Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-132

I saw the same article - same author - in the Herald Sun and The Australian. That was the author I emailed. Before emailing him (and someone else did as well) I googled to see if he was maybe a rookie - he wasn't. In the brief search on his name I found probably a linked in summary that if I recalled correctly stressed his interest in integrity in markets or something similar so, although I didn't mention I'd seen that, I sort of hoped to get a reply even it was only to the effect that - yes I recorded Silviu that's what he said or perhaps no. I'm treating the non reply as either he doesn't want to make Silviu look bad - which he wouldn't at all if he'd quoted him accurately, or that the reporter isn't supper confident that what he put in quotes for Silviu is actually exactly what the FDA said either.

John Maynard Keynes said - when the facts change I change my mind - what do you do? I thought that a good line - but I think the answer for most people is just as pertinent - what most people actually do when the facts change and they are in conversation is (from a cognitive dissonance standpoint) they change the subject (to buy time to process or out of embarasment) and talk about something else.

Here is the full text of the email I sent to Cameron England (perhaps you would have worded it differently - perhaps you might have been briefer - perhaps there's a reason for no reply), Somebody else sent an email as well.

(quote)

Hello Cameron

As a small retail shareholder of a similar company and an ardent follower of Mesoblast's fortunes for the past years I read with much interest your article "US Food and Drug Administration acceptance of Mesoblast data bodes well for growth" in which Mesoblast CEO Silviu Itescu was quoted.

You wrote -

Mesoblast was asked for additional data, and went back to the FDA in January expecting to be told what more need to be done on the study front. (That is not in quotes).

Then

"And instead, what they said was 'no, we've thought this through, and you've convinced us that the clinical data are very strong," Prof Itescu said.

"You've got enough to get approval for children - go ahead and file, and then consider how to take the product into adults".

Would you please confirm that that is a correct quote rather than that you or an editor may have altered it somewhat for brevity or by mistake?

Did you make a recording for instance?

I ask respectfully because I understand that mistakes can occur in good faith but the substance of what Silviu is saying to me reads like he is reporting events involving himself and the FDA in a way that is pithy and makes for good copy but does not seem to me to be how the FDA would speak.

Regards

JB (unquote)