I congratulate management on taking somewhat of a proactive stand this morning with the announcement to keep shareholders & the opportune new investors informed on the progress of the application for CE Marking.
Further kudos must go to the team for anticipating in advance the possibility of additional information being sought & being in a position where they are now able to promptly respond to the request of further info during the examination process.
When filing for such applications its pertinent to answer & respond to only the questions asked rather than pre-empting & providing greater detail which may be irrelevant or create a scenario where the validation process is lengthened due to an inquistive examiner.
The fact that TIS state "After making recent enquiries of the Notified Body assessing the application for CE
Marking of VitroGro® ECM, we have been informed that the reviewers will request additional information” displays again the Management team are proactively pursuing the CE Mark of approval just as much as the current & opportune shareholder is eager to see the CE tick of approval ann.
"Additional requests for information during the CE Mark review process are considered routine & are not surprising to us or our regulatory advisors".
Although fingers were crossed know doubt, they would have sensed a delay would be encountered, as this is standard process. So for the astute investor & current holder todays hiccup should not deter (have a glass of water) but will infact present an accummulation opportunity on any sell off & the following imo is why ..
“We remain confident that CE Mark will be granted in time for the planned start of sales in the UK & Europe at the end of June 2012.”
CE Mark of approval will be issued & Europe sales will begin but yes there will be a delay. Have you ever run late to any appointment in your life ?
TIS VitroGro will be a significant global success in the treatment of wounds.. and I have just the bottle of red to celebrate the success of the share price as soon as this eventuates.
Good luck all and enjoy the weekend where ever you are
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