Why ARNA decides to withdraw the EU application? what is the issue/problem to make ARNA management think it is not possible to get approval? while most of the longs here think approval are almost certain (including PhD Daniel), I think something is way off big time....
It's still the rat tumor issue. If you remember the earlier day 180 Loi there were two major objections one was the valvulopathy the clinical part and the other was rat tumor the non-clinical part. It seems from the CC the only objection left was non-clinical which means the rat tumor is still not answered to the satisfaction of the EU. The good news it seems from the limited information yesterday the valvulopathy issue has been settled with the CHMP and the only thing remaining is the non-clinical rat issue. This can probably be resolved with some more rat experiments which will not cost as much and can be done in a short time frame. Another thing is I hope they will use Fischer rats this time instead of Sprague Dawley rats, as SD rats are more likely to develop breast tumors. I believe someone mentioned earlier that Fen used Fischer rats, therefore they didn't have the rat mammery tumor problem.
The reason they withdrew the application is if they get an official rejection it may affect the applications of other countries as it will be on record that EU rejected the drug. By withdrawing they didn't officially get a rejection and technically it was still possible to get an approval from the CHMP in May even though the chance is small had they not withdrawn. This argument can be used with the other countries so that they will base their review only on the FDA approval.
Sentiment: Strong Buy
If you google "Comparison of NTP historical control tumor incidence rates in female Harlan Sprague Dawley and Fischer 344/N Rats" you will see the article that compares the mammery tumor rates of the two different rats. SD rats have a 40% greater chance of Mammery fibroadenoma and 400% greater chance of delevoping Mammery carcinoma. In my opinion if they had used Fisher rats we would not have this problem today.
Sentiment: Strong Buy
Yep something is way off .Believing scientific opinions people post here as accurate and complete is very foolish. The Short institutions buy advice from top scientists in deciding their decision to short llt not on some message board Nobel Prize winner author.
Forget the science for a minute ;think just business. Will customers in large numbers give up 20 dollar generics or $50 co pay Q for a $250 drug with much lower efficacy for most who try? Can you see the soon to be #4 in efficacy diet drug for at least $100 per month premium and capture a large percentage of the market. Do you think insurance companies will pay $3000 a year for off label products that have not been FDA approved for all the things people think it will cure? That is not reality
Based on the stance that the EU took on Qsymia, I think Arena wanted to wait, perhaps for a year or more of actual sales in the US to gather enough data on safety and efficacy before re-applying. They may have spoken to officials at CHMP and may have been told approval was unlikely, or, they may have just sensed a high degree of skepticism. But I'm speculating. Did they say why in the CC?
Can you answer that? through the 8K, I saw this, "We do not believe we can resolve the major objections related to the results of non-clinical studies prior to the time the CHMP would issue its final opinion"
What does that mean? what is the major objections?