Ann: Appendix 4C - quarterly, page-43

An example of this is the deal Cephalon made with Mesoblast and which won Biotech licencing deal of the year in 2010.

https://www.genengnews.com/topics/translational-medicine/cephalon-shells-out-350m-to-commercialize-mesoblast-stem-cell-therapies/

Now Cephalon did not require MSB to have reached commercialisation at that point. The deal was to provide up front payments AND fund the commercialisation (including FDA approval) process.

It would have gone well but several things happened since then. Teva Pharmaceuticals conducted a hostile takeover of Cephalon and caused the deal to be pared back.

Teva has suffered the indignity of not sufficiently understanding what it bought and now MSB got back it's IP without having to pay for it. Teva just has some equity left.

Teva had excellent people on the ground as an entirely new FDA process was being pioneered. It then got idiots, or bone headed number crunchers, in charge for awhile as they had an emergency on their hands from other deals going bad.

They simply didn't understand what they had and overreached into DRUG trials of other companies, which failed and caused the bottom line pressure.

So it's simply a matter of partnering with someone who really understands the technology and can properly understand the risks.

The parallels on risk with MSB are instructive however. Our cells do not suffer from rejection because the swine DNA has been stripped out.

With MSB the stem cells are manufactured in such a way as to also evade rejection by the patient and allow mass manufacture ie. non-autologous cells. These are oversimplifications for the purpose of discussion.

This removes one significant element of risk to the patient and to a potential investor.

The result is that MSB just has to prove efficacy. Same with AHZ. Efficacy and durability.

Teva behaved like a shark with a lobotomy because they simply didn't understand what they had, and got captivated by wanting to eliminate all risk from the portfolio and concentrate on generic drugs. The people in charge (stupidly) over estimated the risk involved with MSB and confused stem cells with drugs. Entirely different proposition.

Now MSB has moved on after that setback and delay, and Teva are just relegated to being a very minor player as a biotech.

I won't say more about MSB because that's available on the relevant threads.

The moral of the story is this: all we need from a partner is for them to be able to confidently assess the risk involved in gaining FDA approval with our TAVR product.

I think the chances of that are high, after initial trials are done. I don't think we have to wait for FDA approval. I think a clued up partner can assess this and make a deal similar to that brokered between Cephalon and MSB.