GREY:IPCIQ - Post by User
Post by
Priatomaon Jan 21, 2020 1:34pm
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Post# 30578591
Advisor commitee vote and PDF
Advisor commitee vote and PDF
After rejection of IPCI oxycodone in 2017 the company fulfill each and every requirments those were asked by FDA. IPCI perforemd catagory 2 and 3 studies moreover anything-anytime FDA asked the company did. We saw the FDA presentation too together with IPCI presentation. Both the presentation were good enough. Advisory commitee vote negetively and said that they do not want opioid drug any more as its abused. I do not think this is good logic against the product. My point is IPCI product is not worst that other products those are now in the market. I would say a bit better than the reference products. So, why should not be approved? Because any research in this world is meaning of development. IPCI developved the product that could not be abbused by injection. So, its better than any other products in the market now. My another point is just for example: If a Toyota car is very good, but no body can assure that will not get accedent. on the other hand Nissan made a car with same specification that also cannot be assured of not get accedent. But, they both got permission to run on road. I think now the matter is upon FDA whether they will permit or not. To me IT WILL NOT logical if they thumb down.