further communication

I’ve got to say I’m more than a little curious about why TIS made an announcement at all. I was given a clear indication there would not only be no announcement that EMA had sent out a list of questions, but that there wouldn’t even be an announcement when TIS replied to those questions. In fact I was not even given firm confirmation that there were any questions, perhaps because TIS does not give individual shareholder briefings.

So what changed? The timing of the announcement may give a clue. The fact that the CHMP minutes were published the same day as the announcement is unlikely to be a coincidence. The minutes clearly state that a list of questions was adopted. Did the content of the minutes take TIS by surprise? Did they feel some need to provide further explanation? Did they think the market would react badly if it knew the company was being questioned about its product?

So what do the minutes tell us? One thing that is helpful in interpreting them is the fact that a different product is going through the same regulatory procedure at the same time so comparing the wording between the 2 gives us some clues about what EMA is thinking.

“The committee discussed the issues identified in this application…” Identical wording for both products.

Human serum albumen (product 1): “issues……which related to the quality and composition of the product” This wording is missing from the Vitrogro summary so we may be able to conclude that there are no concerns over VG’s quality or composition.

Vitrogro: “issues…….,mainly regarding the benefit/risk of the product as well as quality control” I would have thought the benefit was obvious from prior study data. What about risk? Certainly no adverse reactions have been reported. Has enough been done to prove there is minimal if any risk? Again, I would have thought the fact that throughout all trials there has been nothing adverse would be enough to satisfy them. So what about the final point, “quality control”? Now that is something you could ask questions about. What are the quality control procedures throughout manufacture, packaging, transport and storage of the product? Is that why TIS needs data from a number of different partners? Lots of questions, not many answers!

Of passing interest is the comment in the minutes “members discussed some procedural aspects relating to the CE Mark classification”. I guess that’s hardly surprising given the fact that they didn’t want to classify it as a device in the first place but they can’t change the law on that one…I hope.

So we get back to the question ‘why did TIS feel the need to make an announcement?’ Perhaps they felt further clarity was needed. Unfortunately the wording which was chosen provided anything but clarity. A “few” months. How many?? More than 2, less than 10? “second half of 2014”. Well that’s a whole 6 months of uncertainty. Perhaps they’re determined not to set firm deadlines because of past criticism for failing to meet them.

My opinion and challenge to the company is this (FWIW): this announcement has created uncertainty due to the fact that broad terms have been used. Further, regular announcements should be made to keep shareholders up to date with developments in the regulatory process. Given that one announcement has caused the share price to drop by about 25% I would be surprised if the ASX would reject further announcements aimed at keeping the market informed. In my opinion the first announcement should be immediate and along the lines of providing clarity about what questions have been asked of the company. Of course I’m not suggesting the questions themselves be published but the market should know what matters have been put to the company for clarification. Secondly, TIS should keep the market informed of progress in relation to addressing the issues and particularly when all the data has been collated and response made to EMA.
Sorry for such a long post but I believe all the above issues need to be considered.

Good luck to all long term holders

Rev

DYOR