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16:31
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Originally posted by senoj
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I do not want to be included because I feel many comments are at a tangent to reality. Firstly, the withdrawal of our request for a Scientific Opinion for VitroGro is prudent given that we don't yet know the nature of the studies that will be required. This will become clearer post the SAWP meeting in May. If we had continued with this request it would have been denied - and the effect of which would be worse than the more controlled wait that we are up for. The manufacturing process has been reviewed and approved. The SAWP meeting will centre on the modus operandi of the IGF-1 component of VitroGro - it provides the ancillary pharmacological action. Our trials proved we have a great solution for healing intractable wounds - that is not disputed by the EMA.
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Senoj, Jonesey,
