weekend reading

Question 13.
Why was regulatory Rule 8 chosen for the submission instead of Rule 13.
Answer. Classification of Vitrogro as a Medical Device class 3 under rule 8 was determined by the notified body and advised to Tissue Therapies. This decision by the notified body was based on precedents whereby other devices with similar modes of action had been classified under rule 8.

Here lies the origin of this absolute mess, and its detail has not been given and nor do I expect because its detail will expose the incompetence of at least one if not 2 parties.

My Question 1. What “other devices with a similar mode of action” are being referred to?
Question 2. Do those devices have an ancillary medicinal component incorporated in them?
Question 3. In the original application was it disclosed to the Notified Body that there was an ancillary medicinal component incorporated in it?

If the answer to Q2 is ”yes”, then I fail to see how they could have been classified as Rule 8.
If the answer to Q2 is “no” how could it be possible it was considered that Vitrogro may have “considered similar”.

If the Notified Body was not given full information about an ancillary medicinal item, then they would be at no fault in offering Rule 8. The fault would lay firmly in the lap of Tissue Therapies management.

If the full information was supplied then the blame falls equally in the laps of BSI and TIS management. Remember that both groups are expert in the fields of regulatory matters, BSI because that is what they do, TIS because although they are not expected to know the all regulatory framework, they do have a dedicated expert person (plus consultants I expect) who should know the specific guidelines that are relevant to the vitrogro situation verbatim. (Many on this blog people quickly and accurately made the determination it would be under Rule 13. Its not rocket science.)
If full information was given to BSI, and they still arrived at Rule 8 via suggesting it was similar to other products of a similar mode of action, it implies to me it was done without looking at the written frameworks for making a decision, because it is impossible to arrive at a rule 8 opinion, at least without some serious reservation as to the accuracy.
If this is the case then its gross incompetence, and I can only suggest that as many protective backdoor escape hatches there may be in place, somewhere there must be an accountability section to protect industry from such matters, because without it would dysfunctional.
It has been shown they have a huge range of referral options in place for positions of doubt may find themselves in.

If the decision was reached because full information including the ancillary medicinal component was not supplied then it’s the TIS management clear fault.
As mentioned, the management, their in house specialist, and consultant would/should have known the rule factors backwards and known that if not for certain it would be under rule 13, there would have to be a pretty strong suspicion it could be.

If BSI has come to a Rule 8 conclusion with full information, TIS should have questioned this strongly.

Sure a Rule 8 means an easy road, but you would have to suspect that under diligent scrutiny that there was at least a strong possibility there is going to be a turn around in determination as to the proper ruling category.

If it has been shown that TIS didn’t initially provide full information then you might expect the regulatory bodies would be pretty mad, and will offer no help and favors along the current process.

However, if it is shown that the rule 8 evaluation was made with full information then there should be some degree of admitted fundamental error, with the awareness of its consequences. If this is indeed the situation you may think repair procedures could be available, however the fact it took 90 days for the assessment by the British governing body in making its determination then I can see this is not the case.

Tis’s fear of rocking the boat suggests the error was of their own making, as not to complain fairly of the situation the company found itself in through BSI’s incompetence is pathetic.
Could they have done worse than what has happened. Looks like active guilt to me.
My suspicion is that the company knew all along it was trying to squeeze through something on the wrong rule. It has said it “decided to agree with BSI Rule 8 assessment”. That doesn’t say it agreed with the assessment, it says that BSI have come to an assessment either incompetently or because of insufficient information, and we are going to take the risk and go along with this easier path if it pans out.
That is putting risk into a regulatory system that everyone knows is difficult at best, and to think you would get away with it is incompetent and arrogant, and probably illegal if full information has not been supplied.

Jump to end of March 2012 and the application is submitted, all fingers crossed. Then towards end of May BSI requests more information, about what detail we are not told.
However coincidently one of the directors Banton of Orica capital decides to jump, and resigns as a director. A bit strange, as after so many years as a director pushing towards the imminent success of approval and first sales and the cheer of such an occasion, he suddenly wants to disassociate himself.
Motive? Perhaps when those questions arose for “more information” Tis management knew the game was up about squeezing it through under Rule 8, and knew what was coming down the line. Good time to sell your 760,000 shares, as a crash would be inevitable with the regulatory timeframes that would be probably involved, so relinquish directorship so there would not have to be public disclosure about the action, as the company was still saying to us that they were “confident”.

And we have all been complaining about the lack of information from the company. Well the with the possibility of the above scenario being correct then it would be prudent to say as little as possible.

I don’t know if or how to find the documents involved, such as the original details give to BSI, and the letter requesting more information at the end of May 2012, or if Orica Capital (Banton) sold his shareholding in June. Pretty sure that would constitute insider trading.

This situation has left many shareholders in a precarious situation as put by Brian53 and the support that received. There is risk in investing, especially biotechs as we all know. If these risks have been carelessly elevated by various incompetence’s then that is something else.
I’m a fool for topping up in June when the Banton factor was screwing in my brain at the time, and this has cost me dearly. I’m probably just as much a fool for describing how I see things, should they be true. But what I do know is that there is a lot we are not being told, and the management were not taken to task at the AGM. I couldn’t get there so I can’t complain.
So now we go forward, bottom draw everything those who weren’t smart enough to sell earlier, like me. Why? Because of a faith in the product which I wouldn’t have except for a faith Prof Harding is not corruptible. I don’t care if Mercer stands on his head and tells me it wonderful, I have no faith in anything this management or board has to say. Its just garbage.
So what about the capital requirements for next year. Well as some have said a capital raising to do the US trials should be put on hold. It would be maybe 100 mil shares at 20c = 20 mil dollars which would be needed up front. That is a guess, but if so means a massive dilution. I’m with those who say survive the squeeze to get us through till the CE mark comes when a share price may look better. But of course this won’t happen, and many are waiting in the wings to benefit from this situation and the deep pocket boys I mean.
Us retailers, we are just fodder.
Realistic interpretation, sales at the end of next year, with a massive dilution of another 100 million shares on the registrar.
Thanks Tis management, did you vote a performance bonus this year