We are waiting to find out whether the process of initiating trials has begun because Regen satisfied all of the questions the FDA had with respect to their application. Or, if further questions were posed in response to the answer Regen provided to the initial queries.
If there were no further questions, then trials can be initiated. If there were, Regen will answer these questions (concerns) and wait for a response from the FDA.
As I have stated, since Koos indicated in his 7 June PR that there is a chance there could be more questions (and these questions should not be confused with a clinical hold--they are not one in the same), informing the public of more questions does not fall under the disclosure law should more Q&A be the case. However, when they learn that they are clear to begin trials, they have four days to announce such.
Sometimes, you just have to walk away, let the dust settle and look at it all from a different perspective.
