PS. I found it interesting and initially encourag
Post# of 5066
Posted On: 05/15/2014 2:13:11 PM
PS. I found it interesting and initially encouraging to see that they filed the FDA responses on March 6th, the same day they issued the PR on the Regen dividend.
That indicates to me they fully expected to get FDA approval based on their animal test data and other filings in order to go public with Regen on news of upcoming clinical trial approvals.
They got 2 out of 3 only which means something wasn't right or complete or satisfying to the FDA up front and which took them another month before submitting the revised IND.
Will the revised IND on May 9th succeed in full approval confirmed within next 28 days. I hope so. In fact, if it does, then I think it will be much sooner than 28 days. If no PR within next 28 days to that effect, then something else is at play.
Still hoping that we get some positive news on dCellVax IND in meantime, although from what I've read on science, it's a more challenging issue on the level of medicine.
That indicates to me they fully expected to get FDA approval based on their animal test data and other filings in order to go public with Regen on news of upcoming clinical trial approvals.
They got 2 out of 3 only which means something wasn't right or complete or satisfying to the FDA up front and which took them another month before submitting the revised IND.
Will the revised IND on May 9th succeed in full approval confirmed within next 28 days. I hope so. In fact, if it does, then I think it will be much sooner than 28 days. If no PR within next 28 days to that effect, then something else is at play.
Still hoping that we get some positive news on dCellVax IND in meantime, although from what I've read on science, it's a more challenging issue on the level of medicine.
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