QDIS Blog

There was no love for Advancis from the FDA in this article on Feb 14 when the FDA gave them a refusal to file letter. This is the second one now in the last few weeks.

FDA deny drug application from Advancis - Washington Business Journal: :

What is very interesting to me is that Advancis does not have a press release on this on their website. The last press release they have is dated Jan, 12 2007. This day and age, it is amazing to me that companies don’t react quickly to these sorts of situations. It’s been two weeks since this happened with no word from the company on their website. I understand that time is needed to form a response but something should be immediately announced.

Their Amoxicillin PULSYS once daily dosing is the product concerned and according to the company they were surprised just like Pharmacyclics that I posted about previously at the FDA’s response. The FDA, according to the company, is concerned about how they plan to scale up their manufacturing process to make bulk quantities. Previously, the company had failed some phase III clinical trials which had to be repeated and then had to re-file the NDA in Dec 2006.

I’m wondering if this means the companies are not really listening to the FDA or if the FDA is changing their mind midstream. While this may not seem to be much of difference it could have major implications for other companies getting ready to file NDAs. If the FDA is starting to crack down and not even accept applications, then the industry needs to be much more careful about how they prepare their filings. If on the other hand, these two companies just weren’t really listening and picking up on the nuances from the FDA then it may not have much of an effect on other companies.

I do know from personal experience that you have to be very careful in the questions you ask the FDA. Many times at end of phase x meetings, you submit questions in writing ahead of time and depending on exactly how those questions are worded, you may get different answers. I know of some companies that will only ask yes or no questions and try to word the question so as to get the answer they desire instead of asking questions to really learn what the FDA thinking is on a given set of circumstances. I have always felt this was a mistake. Early on, it is vitally important to ask open ended questions before too much time and money is spent going down a regulatory or development route that may lead to failure at a late stage when it is very costly.

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