Maybe my glasses are rose colored and I please easily, but I am not disappointed. I had some questions on the release, emailed the company and got a timeous and reasonable explanation (and education too). I'm also not free carried and would want 60cps as the floor.
3 main areas queried:
(a) Significance of 40 patients, why only 60% complete and impact on timeline (if any).
Response from Dr. Mercer: 40 is not a magic number (EU regulatory consultant confidant that completed patients in the high 30s would be sufficient) so no real likelihood with the 19 remaining that trial is in danger of not completing.
Delay due primarily to severity of the UK/Wales winter. If there is any doubt: http://en.wikipedia.org/wiki/Winter_of_2010%E2%80%932011_in_Great_Britain_and_Ireland
Weather was also noted in the Half Yearly report as a delay. Didn't get any better for them in Jan, despite TIS efforts bumping up the number of centres from 3 to 5.
As was noted in the results release, EU commercial sales still would be on track for Q2/12 (kudos to mgmt for building in some slack eh?)
(b) The EU trial was for venous ulcers and I understood that VitroGro was to target venous, diabetic and pressure ulcers. Dr Mercer clarified that only the US FDA requires separate clinical trials for approval of each indication. For EU, this trial is sufficient.
I guess the smart BioTech investors knew that but I didn't.
(c) Regarding "device submission" - who's waiting on whom? Answer: TIS has submitted approval and is waiting on US FDA.
So I am not disappointed in mgmt. They are doing all they can to remain on track. I do hold people accountable for timelines for things they control. Weather and government agencies are beyond their control.
Looking forward to the Sep trial completion results.
GLTA
TIS Price at posting:
58.0¢ Sentiment: LT Buy Disclosure: Held
