Ann: EMA 180 Day Review Questions Received, page-20

Hi All

Just wanted to do a screen dump of my thoughts.

While the delay wasn't optimal, in an NPV sense the lost income is almost irrelevant. What is far more important is that the CHMP's issues are becoming easier to answer, and a much shorter time frame is expected (until the next set of questions). As soon as we answer the next set of questions, the clock starts again. So by my calculation as long as we can submit the questions before 15 November, we hit the magical 210 days at the December CHMP meeting, where an opinion has to be given.

If we remember back to the bad old days when the CHMP refused to look at Vitrogro because they wanted to class it as a medicine, as a company we were faced a very bleak and uncertain future. What we have now is a company that is confident it has the answers to the questions asked of it, and a company that has answered to the satisfaction of the CHMP most of the questions asked at the 120 day review.

I understand that the clock stops until the answers are submitted. Even still, the max 210 calendar day for the review is close at hand. So, given that there are no major show-stopping questions that have been asked, we are extremely close to the end of the process.

If that is the case, and if we take the sales projections of the CEO at face value,  then TIS is trading at an amazing discount to the NPV of its future cash flows (Net of head office costs, commissions and production cost). I can understand some discount for uncertainty, but given where we are in the process, what uncertainty is left?

A market cap of $79m against an NPV valuation of $1.6-$2.6b (just for the primary use in treatment of veinous ulcers) seems to beggar belief. I get that sales projections are not sales, but to my thinking the market is saying that there is a roughly 3-5% (80m/(1.6-2.6b) chance of TIS delivering on projections. This seems like a remarkable buying opportunity

Question for Rev/TDA - given that we have satisfactorily answered their questions, on what grounds could a positive opinion NOT be given at the 210 review?