123enen, you should not jump to wild conclusions about the market for VitroGro based on the trial design and results. The TIS prospectus from 15 April clearly said that "the Board believes VitroGro represents a strong potential product opportunity particularly as there are currently no comparable treatments and a substantial unmet need." The upgraded manufacturing under way will produce 350L of the product, when "only a few micrograms is required for each dressing". Assuming VitroGro has a similar density to average proteins of about 1.3g/cm3, 1L equals 1300grams, which equals 1300 million micrograms. Even if they used 1000 micrograms per treatment (rather than the few stated in the Prospectus), that would still allow for a total of 1.3 million dressings from 1L, or 455 million from 350L. They clearly intend to meet the demand presented by the $14B market which will grow to $30B by December 2014.
I suggest you read pages 16 and 17 from the Prospectus, which confirms the opportunities for VitroGro extend to multiple applications and market segments including acute wounds such as burns, surgical incisions, skin graft donor sites, as well as pharmacy and consumer applications. It would be crazy to even think that TIS would limit the application to only chronic ulcers, particularly when they will have the manufacturing capacity to apply it to so many dressings. I would expect all ulcer sufferers would be clamouring for it. I certainly would if I got an ulcer.
I understand that the application for classification as a device has been lodged, and that therefore the timing is now a matter for the FDA, not TIS. It would be most unlikely they would have a different outcome to the device classification already made in Canada and Europe. Even the recent ISO accreditation is for medical device manufacturing.
As a long term investor in TIS for five years, the "wild projections" referred to by 123enen are only wild if you are looking very short term. IMO they are very reasonable and attractive on a risk/reward basis over 3 to 4 more years.
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