TIS 0.00% 0.0¢ tissue therapies limited

Explanation and Expectation

  1. 472 Posts.
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    Hi All,

    Tried to post earlier but my tablet ran out of battery halfway through posting.

    I preface this post by saying it is only my analysis based on research I have done.

    Firstly, what happened last night (yesterday in Europe)? The CHMP published the agenda for their current meeting and it showed that Vitrogro was up for discussion. On the negative side the agenda gives a clear indication that the rapporteur is recommending that the meeting adopt a "list of outstanding issues". Whereas it is not a 100% certainty that the meeting will adopt the recommendation I would not be betting my house on the possibility that the meeting rejects the recommendation and decides to give us a positive opinion anyway. The greatest likelihood is the meeting will adopt the list and this will then be sent to TIS/BSI at the end of the week. The company can't make any announcement about this at the moment because, until they receive formal notification from EMA, nothing has happened.

    Secondly, what are my expectations for what happens from here? It is important to note that the company being sent a list of outstanding issues is not unusual. Of the last 5 published results for medical devices, 4 of them have received such a list. I guess what I am saying here is that it doesn't necessarily mean the company has been negligent in any way.

    The receipt of the list represents a clock stop. Upon receipt of the list TIS/BSI has as much time as they like to respond to the list. That means we could be facing another 6 month delay or more depending upon the nature of the outstanding issues. As for the list of questions, it seems likely the company won't publish them. All I can say definitively is there is still a process being observed here and the minimum  timeframe for a positive opinion is now 20/11/2014 and that will only be possible if TIS responds before 20/10/2014.

    In my opinion it is likely that the share price will fall a little until the company makes an announcement that they have received the "list of outstanding issues". At that point, as happened after the announcement in February this year, the share price will tumble and then hopefully recover. Exactly what happens will depend on the wording of that announcement. We'll then the the same pattern of ups and downs as we have seen since February this year.

    As I said, please don't take this as financial advice and please DYOR. The above is simply my take on where we are now based on historical research.

    GLTA

    Rev

    PS You might note my sentiment and position have changed but I intend to keep a close eye on what happens in the near future and I firmly believe this product will get to market.
 
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