FDA wants batch to batch consistency and Method of Action. No...

FDA wants batch to batch consistency and Method of Action. No trial is going to give you that. Easy to come up with for a small molecule, but not so easy for a biologic cell treatment. I've not seen anything from the company that really addresses those issues. More meetings with the FDA may result in more trials, but won't get us any closer to the finish line. In the mean time shareholders have to have the patience of a Saint. We even have approvals in some small countries, but company doesn't pursue sales, only pursuing approval in US. There's no timeline to approval there and shareholders are going to stop throwing money into this at some point. I've started reducing my exposure.