InvestorsHub Logo

Tekterra

10/26/17 5:12 PM

#30952 RE: Samsa #30950

I don't disagree. They filed these applications years and years ago. It almost sounds like Odidi didn't know about current market conditions. He was just doing his own thing.

Take the more recently filed Ranolazine, or Ranexa for example. Currently, there are only about 6 manufacturers, and those are pretty expensive pills too. So current market looks favorable to get this through approval and will likely get a partnership right away.

But, how quickly can IPCI get approval is another story. If we wait another 4 years, the market conditions will change and there could be dozens of manufactures by then, and competitions may drop the price by a lot.

Our hope is that FDA have changed and they can provide faster approval assuming IPCI don't mess something up and meets all requirement.

One thing I learn about government agencies and not just FDA. They have strict rules to follow and if you submit everything perfectly, you're likely to move through the process before everyone else.

If you mess up and miss things, or not have sufficient required data or even a form not well filled out, they put you back in the piles and you would be lucky they find time to dig it up again and approve it some times in the future. It's critical IPCI try to do it right the first time because they will look at the new applications, and you get that first impression right it will help a great deal.