Posted On: 10/07/2013 7:35:56 AM
Post# of 5066
In response to On Ice that will undoubtedly be deleted:
That is so far from the truth--from the beginning I have posted multiple links and quotes from various organizations outlining why 30 days for approval does not happen for 99% of IND applications, especially for those with little or no experience with working with the FDA. I have even highlighted the "exceptions" of protocol, none of which Regen/BMSN qualify for.
I have maintained that the 30 days is a fallacy, made up by people that do not know how the system works and were holding on to a pipe dream. I did argue that it should not take six months or a year for FDA decision as some argued. However, that was before certain issues arose and the full implications of the issues were known (the Oregon State mishap and the trademark change and now the government shutdown).
Stop misrepresenting my words and falsely accusing me of things...it is kind of creepy your apparent obsession with me.
That is so far from the truth--from the beginning I have posted multiple links and quotes from various organizations outlining why 30 days for approval does not happen for 99% of IND applications, especially for those with little or no experience with working with the FDA. I have even highlighted the "exceptions" of protocol, none of which Regen/BMSN qualify for.
I have maintained that the 30 days is a fallacy, made up by people that do not know how the system works and were holding on to a pipe dream. I did argue that it should not take six months or a year for FDA decision as some argued. However, that was before certain issues arose and the full implications of the issues were known (the Oregon State mishap and the trademark change and now the government shutdown).
Stop misrepresenting my words and falsely accusing me of things...it is kind of creepy your apparent obsession with me.
(0)
(0)
