Hi redgum,
Thank you for your insights. You make a strong point about the fact that VitroGro had been held in storage for a lengthy period before it was replaced. It could be argued however,that since it was in store it wasn't being used on patients so it's efficacy wasn't clinically tested. It was simply the manufacturer's assurnce all was well - and we don't know how often it was sampled nor how it was tested. I do know TIS were keen to make it last as long as possible.
I accept I could be completely barking up the wrong tree - so to speak - but I'm confident the issue is clearly scientific and relates to data TIS haven't provided or only partially provided or haven't got at all. As I said in an earlier post the FDA have already discussed with TIS the need for additional data albeit after the US trial - EMA quite rightly want that ot similar data prior to giving marketing approval
My gut feeling is that the issue lies in the novel and complex protein they have created.
I have interpreted the following part of the announcement by TIS to support my contention the issue is a scientific matter. This is reinforced by the fact TIS will meet in May with SAWP (scientific adsvisory group) for data requirements and directions.
The Committee for Medical Products for Human Use (CHMP) stated to the Company that it wanted additional data regarding one of the components of VitroGro® ECM. 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.
The company is pleased that EMA and the Notified Body are assisting the Company to determine a definitive solution.
Hopefully, all can be sorted in the next 6 months as the competition is closing in - see the very interesting post by thymus
Cheers
TIS Price at posting:
11.5¢ Sentiment: Hold Disclosure: Held
