Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-828

While we wait impatiently for a significant announcement and play "wackamole" with the non-holders, I thought I would share my thoughts on the current situation:

I believe this whole change in "attitude" by the FDA, caught the BoD by surprise (a pleasant surprise nonetheless), and that this significantly adds to the importance of the BLA submission announcement, for the following reasons:

• If they were aware or had any indication that the request to submit a BLA was on the way, I feel that they would have delayed the CR to try and achieve a much higher price . Whilst most LTS are a tad miffed at the CR due to price and dilution, it also had the the same impact on the likes of GG and SI (who have significantly higher exposure to the consequences of a CR), so it was in their interests to obtain as high a price as possible.

• The BoD share purchases both in size and timing, if there was feeling that the FDA were heading in the direction of a new BLA submission one would think they would have been buying earlier and at lower prices (obviously taking into account the regulatory requirements). This didn't happen (I recognise that GG & SI bought in the CR, and GG then continued to buy).

• The fact that the BLA submission is taking longer than perhaps would be the case if they had an idea it was coming ie they would have been more prepared.

• The almost excited tone of the announcements about the relationship with their new BFF (the FDA).

If this assumption is the case, it would seem that it indicates far more of an FDA initiative rather than a coerced response driven by MSB.

If true, this adds significant weight (and is far more meaningful) to the BLA submission, sending a real signal of "we have changed our view of stem cells".

Just my thoughts and interpretation of events, not advice.