1) Yes, the CHMP did not express concerns about the performance of VitroGro® ECM, but allow me to be more precise: the committee did not express any opinion about the product, it did ask for further data instead.
If you can find anything in the official meeting documents that do express an opinion about the product's performance then please let us all know. We need this affirmative expression - it may be the last straw for many true believers.
2) Re your sentence: The FDA has requested additional data from TIS, albeit after the trial. You are joking, aren't you? If you are not joking then please provide proof of this statement, proof that resides in the public domain, of course, and not in the wishful thinking of HC-TIS posters.
NB: Out gut-feeling is the same - the only difference is that I estimate it will take at least another year and many $s more for the CE-mark, and at least two (if not more) years to get the FDA approval. Have a look at the outgoings (see attached pdf) and you may be able to get a feeling how many $s are needed (judging on past spending). In the meantime the competition is gearing up and that, for sure, invalidates all the nice forecast spreadsheets of some posters. Should you not be able to find these spreadsheets feel free to contact me - the links are readily accessible.
