TIS 0.00% 0.0¢ tissue therapies limited

I emailed the Company three times over the past week and finally...

  1. 894 Posts.
    I emailed the Company three times over the past week and finally had to telephone them to get to talk with someone. I gained no new information from the Company. IMO we will not see TIS sales until next year. My reasoning which I conveyed to the Company last week is below.
    As already mentioned the Company are still collating the data and will make an announcement when the submission is made to EMA/CHMP.
    Initial CE Update 26 Feb 2014: “Assembling this manufacturing data will take a few months” this has extended to beyond 5 months and knowing that there is no CHMP meeting in August, the next meeting is 22 - 25 Sept (seven months). At this stage TIS are 120 days through the scheduled 210 day process with potential “Clock stop” at 180 days. Even if no “Clock stop” the remaining 90 days of the process would take TIS through to 25 December 2014. The CHMP meeting in December is 15 – 18th so TIS’s submission opinion might have to wait until the January CHMP meeting to be ratified by the committee.
    Now the CRUNCH: It has dawned on me that whilst everyone is talking about a favourable EMA opinion, IMO what TIS need for the CE Mark and for sales to start is to have an EC decision (which is legally binding).
    The EC can take another 67 days to issue a decision. IMO a realistic case would have an EC decision by end of March 2015. The latest Quarterly report confirmed TIS expenditure $1.7M/quarter with only $7.0M cash reserves potentially leaving only $1.9M in the cash reserves as Vitrogro sales start (not including $1M for potential inventory replacement). IMO there will need to be another CR to fund the US FDA Approval and the roll out of Vitrogro until the first sales receipts are realised (end of second quarter CY2015).
    DYOR.
 
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