Analysis of the EAP, page-446

@tuhorangl,

I am a "fan" of the USA which transcends the short-term administration of any of its 45 Presidents... not sure how you've reached your conclusion based on anything I've posted? Again, my goal is to describe and analyze for readers from afar the complexities of the US regulatory system as it may impact Mesoblast, not to debate partisan politics. I'm not here to promote any political or even national agenda... just a corporate one from an investor viewpoint.

I've been enjoying the discussion on M&A, and how the company's structure/charter may impact that... I can use some education there as a foreigner. Until April 6, the company's strategy seemed straightforward to me... file a BLA, become the first ever FDA-approved allogenic off-the-shelf stem cell therapy, target a relatively small and very well defined pediatric indication with a small sales force dedicated to a dozen or so university tertiary referral centers, and then, building on that foundation, conquer the world sometime down the road...

The abrupt change of course less than 2 months ago certainly permits investors to scratch their collective head on strategy and pose different scenarios. After all, we're hearing that Gilead, a $100 billion company headquartered in the USA that mixes up a small molecule in a test tube, IS UNABLE to meet demand following the issuance of an EUA by the FDA. Granted, they are targeting a larger population of ER and hospitalized patients, not just ventilated patients, but the point remains that for an indication that has no approved therapies, the supply-demand equation can change rather dramatically overnight.

Mesoblast is potentially 1 to 2 months away from having a similar "problem" to GILD... even if the odds of that happening that soon, at the first 45-patient checkpoint, are in the range of 10% (my estimation) the BoD would be remiss not to have some type of contingency plan in place... so when the only thing we have to go on is "We are in discussions with...", I certainly take them at their word. After all, this is a voluntary change of course, I don't believe it was embarked upon with the idea "same strategy we're using for GvHD will certainly work for C-19, just substitute a sales force of 10-15 with one large enough to handle EVERY ICU in the US and eventually the world" ... NO, management has deliberately put the Company "in play" and it's part of a larger pre-planned strategy only a few seem to glimpse.

I think there are many possibilities, but I look for some type of"partnership" announcement before the first interim readout, if for no other reason than to allow time for preparation on how to coordinate a complex, flawless rollout of product together... imo