Hey Guys, great discussion. GL, your not missing anything imo apart from the inherent risks GKM points out, the market stays cautious for a long time with BIO's but when it turns it is swift and will catch you by surprise, this is why I like to get set earlier and all it takes is for one to take hold and away we go. Personally I have not seen too many like TIS, the chance to be the "Standard of Care" doesn't come along very often and is why I am here.
It's true that the US is the biggest market, but what I like is the fact that TIS are going around what might be a lengthy wait for approval there and hunting down the rest of world market, this is a strategy starting to be used by many emerging companies. It's very well known about the delays currently seen with FDA approvals as they are under staffed and cannot keep up with submissions for approval for many drug sectors, NDA and ANDA.
So, what would FDA do if a proven and effective technology is accepted everywhere else apart from the US is being used and is cheaper (helping reduce healthcare costs to the country) and more effective than current standard practise?? My thought, they wake up and take notice:)
It was mentioned at the AGM that TIS are starting discussions with FDA, something about current trials and being used for parallel purposes, once again. I'm not sure exactly so please don't quote me on this, I will however try and clarify this and get back to you guys with the response I get.
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