Hi all readers,I know this topic is old news, but in my view...

Hi all readers,

I know this topic is old news, but in my view that doesn't diminish the relevance or the depth of this disaster. In fact, this failing has never been acknowledged by TIS management and hence it could happen again - as the very same people are still running the company.

Point 1 - ASX Announcement on 30/10/12 "Device Classification Confirmed"

After saying VitroGro had been classified under rule 13 and now required EMA review that would take at least 210 days, the ASX announcement said this...
"The EMA submission is already substantially complete. Preparation work on this has been ongoing since early August, in case the EMA review was required. The required format of the EMA dossier is an international standard called the Common Technical Document (CTD). This format is well understood by the Company."

There you have it. "This format is well understood by the Company." TIS (and BSI I assume) are working on the EMA submission and it is largely complete, and the process is "well understood..."

It was submitted sometime in Dec2012/Jan2013

Point 2
On 18 March TIS announced to the market as a "Regulatory Update" that the EMA had rejected their submission and they held the unofficial view that VitroGro was not a medical device.

The 18 March announcement by TIS stated... "Following receipt of the 13 March 2013 email from BSI, Tissue Therapies arranged an independent expert review of the submission by BSI to the EMA. This assessment indicates that the submission to the EMA was poorly constructed and did not provide adequate information for the Medical Devices Group."

Note that in this announcement they say that it was the submission "...BY BSI TO THE EMA..." (!) that was rejected. TIS management don't mention any personal involvement in the submission. WHY?

Now if you read the qualifications and experience blurb on TIS's website we are told that TIS senior management are highly experienced and qualified in this sort of stuff.

TIS would or should have known exactly what was in the EMA submission, and they have NEVER apologised, or even admitted, their own central role this appalling and hugely costly lapse. The submission was substandard and obviously misled the EMA committee into thinking VitroGro wasn't a device.

Idiots surrounded by fools.

Sorry to bang on about this, but it is something that TIS knows and in my view has willingly ignored and glossed over, whilst going on as if it is business as usual.

It's still bonuses all round I guess.