The most specific item I saw is this:
<<In the complete response letter the FDA requested a thorough QT study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol would be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON.>>
That is clipped from this article: http://www.rttnews.com/content/BreakingNews.aspx?Id=1449736
Now, I get the first part. The QT is an interval that can be measured on an EKG (heart rhythm tracing) which is part of the normal cycle of each beat. However, if you have a prolonged QT interval, you are prone to rhythm disturbances, some of which can cause sudden death. Some QT syndromes are inherited, some develop on their own, and many are caused by medications. Apparently, there may be some problem with this drug at high levels.
Then, the report gets a little fuzzy. It states, "Additionally, the FDA has now requested the results.." That sounds to me like the QT issue has been mentioned prior to "now."
Then, the report gets MAYBE somewhat worrisome for us HGSI shareholders and that's why I am asking for expert opinions. The news report states the FDA has "Requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON." What I take from that is that the FDA wants for AMLN to do a completely new safety and efficacy study of the "COMMERCIAL FORMULATION" of the drug. This implies, to me at least, that the results of the "Phase 3 formulation" (for lack of a better term) of the drug is not good enough. It seems that the FDA wants them to test a commercial batch of the medicine. If this is so, may not the FDA want to test a commercial batch of Benlysta before approval?
The article below may provide some answers to your question and why Amylin's problem is not relevant to Benlysta. The bottom line is, Amylin had too much assumptions and did not go through full NDA and trial process.
Bydureon is a once-weekly version of the diabetes drug Byetta, which is currently sold by Amylin and Lilly. The two drugs share the same active ingredient, exenatide, so Amylin and Lilly relied heavily on Byetta safety data and sought FDA approval for Bydureon under the agency's so-called 505(b)(2) rules, which is designed to save time and money compared to filing for approval as a full-fledged New Drug Application, or NDA.
The hedge fund manager, short Amylin, continues:
"Amylin and Lilly consistently called Bydureon a line extension of Byetta by design because it made investors feel comfortable that approval was not going to be a big deal. But when you look back at other companies that developed new, long-acting versions of their own drugs, you see that they filed full NDAs and chose not to use the 505(b)(2) shortcut."
Thanks, to be,
It seems they didn't test their version enough. There were certainly no short cuts with Benlysta. Add to that the fact that AMLN's drug is a me-too med vs. the first new drug in over 50 years for lupus Benlysta. I think we're sitting pretty and I'll reiterate that the delay in the AMLN drug benefits the potential market share of Syncria.