The needle comparison was not my post (I would never write something like that), so perhaps you should get your facts right and need the help in research since re-reading a post seems too difficult.
I realise re-approval is required and as stated the 505(b)(2) is a form with the purpose of faster processing of these changes, including exclusivity to market.
I have not posted any misleading information. If anything, you are posting information that this technology is at least 6-8 years away which is so black and white that I have to disagree with you. These things by nature are always grey. While some approvals may take a long time, not all will. OBJ technology is applicable for many drugs, some of which will require more scrutiny than others and will undoubtedly take longer than others.
Here is an example of a practical timeline I have found for you:
"In the Fortical approval, Unigene press releases indicate that the NDA was submitted March 6, 2003, filed by the FDA on May 5, 2003, and issued an approvable letter on January 8, 2004, within the PDUFA standard review 10-month goal."
I won't explain the above quote as you seem to know all about the FDA or maybe ask the biotech executive? This is by no means a definitive timeline for EVERY single case, but I'm contesting your argument that you say it will take definitively 21 months for processing only and 6-8 years for final approval. Again, these things are rarely black and white.
Anyway, I've made my point and I've heard yours no need to continue. Make of my posts what you will. I don't particularly want to continue arguing. Please, stick to posting your rebuttals to my argument instead of personal jibes.
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