A Little More Research, page-14

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26/03/15

12:48

Post #: 14984850
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Originally posted by Revreboot ↑

The problem I have with the way this unfolded and one of the reasons I have sold out is that there were other options rather than withdrawing the application. Other companies have received a negative opinion as a result of an oral examination and have then been granted a re-examination. At least one of these satisfied all outstanding issues and was subsequently granted a positive opinion. The time frame for this to happen was about 5 months. The withdrawal of the application then must have been influenced by the proposition that the issue was not something that could be resolved within that sort of timeframe. The additional data IMO is likely to require additional trials. My suspicion is that they are not satisfied with the original trial size and that it sufficiently establishes safety of the product. This is a suspicion only and only time will tell.

Rev

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I agree with you Rev and have had those suspicions ever since FDA didn't go down the device route and requires additional trials.
The CHMP did not express concerns about the performance of VitroGro® ECM, but is seeking additional data from the Company.

Tissue Therapies will attend an EMA Scientific Advisory Working Party (SAWP) meeting during May 2015 to agree on the studies that will satisfy the request for additional data.

Sorry to see this happen to holders who have stuck it out for the LT, all the best guys!

TIS Price at posting: 13.0¢ Sentiment: None Disclosure: Not Held
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