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Monday, October 06, 2014 7:13:13 PM
I actually am pleased that company released a PR on this today which gives more transparency of the process and allows for investors to make better decisions. More communication, more chance for building trust and confidence that company will keep you informed. Something that's needed if this is to get beyond "flippers stage".
So we can still look and hope for dCellVax IND this month and an FDA response next month on that while HemaX looks to be delayed until 2015 to carry out the new safety experiments.
That's not what I'm gathering from this PR. It sounds to me like they just submitted an experimental protocol for a preclinical experiment to the FDA for approval. Once the FDA says that they think that protocol will be sufficient to prove the safety element that Regen has been trying to prove to the FDA's satisfaction Regen will have to perform those preclinical experiments and then submit that data.
So in essence, it sounds like they are trying to make sure these new experiments will answer the FDA's questions before attempting them.
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