Like I said previously when we received the announcement on 2 October, I have put my faith in Dr Krause, Dr Itescu and Dr Rose ... this long term data was obviously a key component to the BLA resubmission and that is what they were waiting for
In the interim they also submitted substantial new information for the IND back then as per the advice from the FDA through their "active dialog" and reiterated to the market that Remestemcel-L has both a Fast Track designation and a Priority Review, which indicates the data submitted 6 weeks ago is probably already being reviewed .... again I think the 3 amigos mentioned above know what they are doing as opposed to the anonymous posters on here
The long term data released this morning is extraordinary ... let's hope the FDA draw the same conclusion ?
GLTAH
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-9
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