Belviq application was withdrawn so that the reasons for a pending EU rejection were kept confidential. ARNA indicated they had an OE and obviously were informed of a negative trend vote. If the Belviq application had not been withdrawn, a CHMP rejection would detail the basis for the rejection. ARNA withdrew to protect pending regulatory proceedings in Switzerland, South Korea and Mexico. Additionally, it is possible that a concern of the CHMP/ PRAC might have had to do with the abuse potential of Belviq. If so, it would also have been in ARNA's best interest to keep that EU concern private, in an effort to not impact the ongoing DEA scheduling process. It was clear during the CC that ARNA management would not comment on the reasons for EU application withdrawl, and are hiding the basis for their decision.
How can you call your comment unbiased when you have not proof of your statement. Did Arena say that was why? I agree Arena management dodged the question when asked for the specific issues that were raised by the CHMP. But your comment is purely your OPINION of why they withdrew the application. You have no facts. You are bias.
I don't think they are hiding the basis for their decision. There is some logic to a lot of your post, but we will get some indication since withdrawal reports are put on the EMA website. Will that give exact detail, probably not but will provide some insight.
Sentiment: Strong Buy
Another way to look at it is they could (a) force CHMP to give a "No" on the application (like V did), or (b) do a short non-clinical study to prepare an airtight case and resubmit later. They said non-clinical which means lab tests, not extensive trials on people.... this is something Arena can do in house.
Also keep in mind none of this EMA stuff is within the current scope for Eisai and with Belviq launch coming soon (any day now) this allows both Arena-Eisai to focus on that. PRAC and CHMP meetings ended last week and on Friday the 26th, they announced the quarterly CC date, so it appears that they just shifted the qtr report to cover both at the same time. Makes sense even though I didn't like the surprise.
Just think though...... If this application had gone through as planned (and after US approval, the basis was there), the 2x positive timing with could have been spectacular for longs.... oh well.... bad for my short term trade positions, but ok for my long term core investments.... just trying to keep it in balance.
Fear, Uncertainty, and Doubt (FUD) will be spewed from all available nozzles.....
BUT the launch remains on tap and after a little time the Bel-phen aspect of this will sink in..... shortly after launch I expect this to be expanded to also include a label expansion study that will include Bel-Metformin and dose optimization for T2DM..... even the design of those studies will create news.
I think you misunderstand. The "non-clinical" issues (e.g. tumors in rats or mice) cannot be resolved by non-clinical studies. They would have to stage long large and expensive human trials to prove that the same things don't happen in humans. This could never happen. Assuming that the DEA schedules Belviq, the American consumer will now be the guinea pig.
The FUD has been brought on ARMA longs by their management. For instance, if they really wanted to be upfront, the could have had a representative from Eisai available to discuss specific Belviq launch preparations, DEA update, etc... instead they punted. This produces FUD among their most ardent supporters...
Prepare to be stoned and thumbs down from the faithful. Your rational most probable factual analysis of the situation is very threatening to the retail longs. This does not bode well for the unrealistic expections they have clung to in this highly speculative risk.
That might be an unbiased opinion, but it is based on very little information. The CRL studies that ARNA did for the FDA had some inconsistencies, but given the hurried nature of those studies (and they were hurried - take it from a guy who does this for a living) overall I was satisfied with the results. The inconsistencies were the kind of thing that could be cleaned up statistically with another round of experiments...another round of experiments that could take 6-12 months. Clearly this would not happen within the CHMP timeline. But we don't know what the CHMP wanted...and ARNA might not be completely clear on it either, so at this point this is all just wild speculation.
Your point is valid... no one knows the nature of the non-clinical issues, except ARNA management-- but they are going to keep it a secret. And the only reasonable motivation for that is to protect pending regulatory filings and the DEA scheduling process. Leerink Swann anaylyst has now been quoted by Global Regulatory that they do not expect DEA Scheduling or Belviq Launch will occur before second half of 2013 (i.e., not before July). ARNA management's intentional lack of clarity on the EMA issues will further hurt pps during the next few months.
best part of the CC is how you can tell me you won't delve into the reasoning behind the EMA concerns and yet you knew to pull the plug??? This company is dirty which stays consistent with biotechs. When I break even I will take all of my money and put it in Merck or Pfizer. They ain't broke biotechs cheating investors of important info.
They were non clinical issues and the abuse potential was in the clinical studies, so I do not believe the abuse potential was the sticking point. The non clinical studies were the studies down to satisfy the CRL so they must have had issues with them, the way they were done, the inconsistencies in the data. It is all guessing right now, we won't know until they get the report and work with the EU experts on the science to answer those questions.
Some additional thoughts... ARNA said EMA issues were not resolvable within current Belviq MAA timeline-- so,
1) EU rejection was likely not due to concern related to Swiss manufacturing facility... this would/ should have been able to be addressed inconjuction with ARNA response to LoOI
2) EU rejection more likely due to cardiovascular, cancer or hallucinogenic concerns, and recent JACC abstract which indicated that Belviq was associated with dose-dependent worsening of valvulopathy may have played a role
3) reapplication in the EU not likely before Belviq CVOT results available-- and ARNA management that this protocol is still under discussion with the FDA, and is thus delayed
4) Qsymia CVOT study results will likely be available well before ARNA, based on VVUS management's statements that CVOT will begin enrollment by Q4 2013, and will allow Qsiva MAA resubmission before Belviq
Hmm, not buying this just yet...ON CC, Arena said that they did not have enough time to respond to pending questions (Nothing new outside of those presented in the 180 questions). They simply stopped the clock to give more time to respond. What Arena does needs is a local player helping them out.
It was not enough time to respond to pending questions. You need a hearing aid and to take a reading comprehension course. They did not have enough time to conduct a non-clinical study that would help to resolve what is probably the last objection.
Sentiment: Strong Buy