Let's see: CHMP is doing a sort-of a peer review of a product to be introduced into a market of approx. 500 million people. The members of the investigating panel have, and we can safely assume that, the same or higher credentials than the applicant's staff. They are simply asking questions and want satisfactory answers.
As we know now TIS has not provided these answers. Why? I don't think it is incompetence on the company's part - I rather believe, in true up-ramping style, that they deliberately chose not to answer these questions because it would involve the public disclosure of proprietary information. Hence the negotiation in May re how to do it.
Efficacy is not important as far as CE mark is concerned - for the US FDA approval it is. The withdrawal for scientific opinion simply reflects the fact that there was and is no proper clinical trial data available.
As everybody on this board does - or should - know:
Contrary to popular belief there never ever was a proper clinical trial for VG.
There was one, and only one, study in the UK (2012, 54 patients,
http://www.vitrogro.com/clinical_data.cfm) and no further studies have been made available. Please feel free to correct me if I am wrong - but please do me a favour and post the link to the actual trial.
Now with the benefit of hindsight we can say that TIS tried to do it the quick and cheap way and went into this exercise inadequately prepared. As a result we, the SH's (and management of course), get presented - once more - with a delay. This delay does put a big question mark on the investor update from February 2015 (
http://www.tissuetherapies.com/uploads/Investor Presentation.pdf). Each and everyone of these presentations, past and current, have proven to be wrong - and it is time that the board and management be made accountable for that.
In addition we have experienced over the past three month's multiple occurrences where shares have been offloaded prior to sensitive announcements. With so many parties involved - Logistics, Support Services, Consultants, PhD's and other high-IQ Academicians, not to forget clairvoyants - it is no surprise that this ship has leaks.
Basically, this delay it is just another roadblock on the long road to fame and glory and I feel sorry for our board that they must shift the performance goalposts for our CEO again - like they did last time. But with our top 20 SH's and QUT happy there is no reason why this board and management should not continue to enjoy their lifestyle - there surely is enough money left from the last CR to tie them over for the next six to nine months. They specifically said that the raising of A$7.7 million is to fund the completion of the EMA review (with prep work for the FDA trial preparations - maybe).
