Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-505

I have dealt with the FDA over a couple of decades in my professional work. I am familiar with its communication style, terminology and limitations in language at each stage of the approval process. I am comfortable what was announced by Mesoblast. I have also become unfortunately very familiar with SI's over optimism and am aware of the roadblocks FDA has put in place since the ODAC meeting and subsequent CRL's . The announcement used key FDA phrases unrelated to SI's weakness to allow me to make an objective decision. The only risk I have is if after the numerous law suits against Mesoblast and SI's communication, their lawyer's have signed off on a deliberate lie and invalidated their Director's Indemnity insurance. I put that as a low risk but maybe SI and his directors have put all their assets in their spouses names and Family Trusts. Well done, they got me on that one.

Note, I had bought trading parcels prior to the unexpected announcement. I ditched my trading plan which was to take some profits after certain technical indicators had been hit, once I read the announcement. Since then, other technical indicators have justified holding off taking any profits. Some of those trading parcels will likely now be investor parcels, depending on further positive news events. I am investor at heart but have had to add TA skills to help interpret shorter term movements in the share prices. It's certainly not my forte.

Many will wait for the official FDA minutes after 30 days (or even approval day). I can see why they would do that. I suspect the same risk/reward opportunity will not be there at that time. So yes, I have extrapolated certain likely outcomes from the announcement. This is how I trade/invest/speculate; use any slight market edge I may have. I'm sure others have science edges, technical edges, manufacturing edges, management insight edges... The difficult part is knowing if new information related to your edge has any difference on the value of the company in the short, medium or long term.