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TIS - EMA position may be reasonable, page-3

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Puzzled

1,858 Posts.

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26/03/15

16:47

Post #: 14986916
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Originally posted by amcfutures ↑

I’m wondering whether the EMA has decided it requires the same surety regarding stability that the FDA requested (ASX announcement 5/12/2013 part below). If that is the case then the trial conducted expressly for the EU (see below) won’t suffice.

The FDA has requested Tissue Therapies to provide a plan to develop an additional quality control test for manufacturing and stability. The scientific and clinical results demonstrate that VitroGro® ECM is stable and effective in use but the FDA has requested this additional final test and the Company has agreed. The additional test requested by the FDA is to detect a theoretically possible change in stability that the company has not observed with extensive testing to date.
It is not a requirement for this new testing to be complete for the Company to obtain approval for the venous ulcer clinical trial to proceed. The FDA only requires a commitment from Tissue Therapies for approval to be granted.

If I’m on the right track it seems like the EMA actually want the data upfront before making a decision. Frankly, I have to admit that it’s the sort of information I would request if in their shoes.

I vaguely remember discussing something like this with TIS to try to establish what the issue was. My even more vague recollection was that the main protein used in the Vitrogro compound is a novel ( new) combination of two key proteins – one of which was known to be stable while there was still work to be done on the other component.
If this is the case TIS have known about the issue for a long time but may have assumed that if FDA didn’t need the information upfront then EMA wouldn’t either.

I accept that I may be completely off-course but it’s the only possible explanation that comes to my mind.
Re-trials
The EU trial to end all trials – not so it seems. I think it was overseen by Prof Harding. http://www.asx.com.au/asxpdf/20111111/pdf/422gf8kghlw1mm.pdf
There were some trials conducted by Health Canada but can’t find the results.

Expand

amc, your guess is as good as any. It makes sense to me that the EMA would want this same data upfront as the FDA. The blast from the past (the trial announcement) shows with hindsight just how overly optimistic management have been through the whole process. Instead of 2nd quarter 2012 sales it seems that the earliest we can look forward to sales is over three years past that particular estimate.

I am hoping that their confidence in the quality and stability of the product is not similarly misplaced.
I am taking some heart from the trading today. It wasn't as bad as I thought it might be. I wonder if we will see a few notifications about increases to substantial holdings over the short term?

TIS Price at posting: 12.0¢ Sentiment: Hold Disclosure: Held
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