This is my fear now. Will physicians prescribe belviq at the same rate they would have if the EU rejection had not become public knowledge? Will patients have concerns now? Has the risk/reward equation changed in the physician perspective? Could this depress sales? Perception can be more powerful than fact.
It's a withdrawal not a rejection. Note the difference.
Qsymia was rejected then appealed then rejected for the 2nd time. Did TWO rejections end Qsymia sales in US? NO.
If interested in reasons why EU insist on rejecting Qsymia then Google for PDF document WC500139215
IMO, give it another year of actual Belviq use data coming out from the US and the EMA "major objections" issues will be put to rest. It is very important to remember that the CHMP did NOT flat out reject or had a negative opinion (as stated in your post), they just are not sure and obviously ARNA did not satisfactorily address all their concerns, whatever those concerns may be. I think CHMP was most probably looking for more Data and that is not necessarily negative for Belviq; therefore, US Physicians perception should not be affected compared to how it would have been affected with a negative opinion coming out from the EU.
I doubt that news of EU withdrawal will change anything for the health care providers decision to cover the drug. Weight loss is still a major problem, type II diabetes is still a major problem, doctors all know another tool is needed for a segment of the population. The only concern Dr's listen to coming from the EU is results from drugs approved in the EU are patient results, and safety issues from mass population use published in journals, articles, further study, etc. All know that 100,000 patients yield a true picture vs. trial studies of a few thousand patients that are more selective on patient profiles, and study designed controlled outcome information to satisfy the end needs for regulatory approval. Actual, in practice use gives the results, and safety profile they seek for their patients. My view, it will effect investor's confidence more so than the individual doctor's. Just my opinion, and the sentiments of my personal doctor regarding pharma drugs in general....his comments," All I have time for is to review current practice profile's, and results. The drug company is the last one to provide negative information, and the first one to provide good information."
And to add to my earlier comment there is one more binary event awaiting ARENA ... and that's the DEA decision.
Right now DEA decision will be the biggest catalyst that will determine no sales or some sales. The DEA decision will also impact the PPS
Not a rejection at all Taylor, they withdrew the submission. You need to start your post all over again from scratch. Might just be best to completely forget all questions you just proposed as the premise is 100% incorrect. Must have some nut jobs working the boards today for this to get three thumbs up.
The withdrawl is actually worse than the rejection of Q. They told VVUS do the CV studies the FDA wants and come back and discuss results. Also your product works well. For ARNA the Dr's have no idea what the EU considers as bad enough to reject . An unknown that will hamper US sales. Europe said about Q that it works well but want more long term test results
eu withdrawal, not rejection, that is why they withdrew so they wouldn't be rejected and that will allow them to easily reapply. 2010 crl from fda, 2012 fda approval, 2012 eu withdrawal, 2014 eu approval.
IMO van.....The EU, specifically the CHMP will issue a formal report to ARNA. Unless it is a new issue not raised by the FDA or DEA, then they do not have to tell them anything. If third world Mexico rejects B do you think they will send a copy of the report to DEA. We are dealing with multiple countries across multiple continents who each have their own set of rules.
DEA will not be influenced by EU, Mexico, S.Korea......they are all separate. Approval in one, does not guarantee approval in another. JMO
Thank you for sharing your concerns. I have personally decided that the FDA is the premiere regulatory agency in the world and their approval speaks loudly enough to counter any perceived negative associated with ARNA's withdrawal from the EU process.
Belviq was NOT rejected, BTW. It was withdrawn. The EU was possibly looking for something that Arena could not adequately address at this time. Just like the original FDA panel wanted more information in 2010. Rather than risk the same course of events, Arena decided to pull the plug on the process, concentrate on the U.S. launch, then take a different tact on getting back into the EU. It is possible that part of this process could involve a EU partner.
Questions like yours make sure people do their homework and actually advance the effective knowledge of all investors in this company. Thanks for asking...
Folks: I am sure there are some doctors somewhere out there that will give pause to dispensing Belviq because of this EU delay, but not many--most will follow the FDA and its approval. Thats much more comforting to them than some VVUS trashing exercise i the sales world! There are also some doctors who are going to let the just let others test drive these drugs first whether its Belviq or Qysmia before using them themselves!
I am also sure VVUS will use their sales staff to spread stuff with their physician contacts as well!
But think about it! ARNA problems with the EU are over rats and VVUS problems with the EU are much more serious #$%!
I wouldn't be accentuating this difference in perspective between the drugs in doctors offices either and that exactly why you can count on VVUS to do it! Because they have demonstrated they will do anything to keep from losing and they are going to anyway!
I think Donco's earlier comment is spot on, but VVUS is just that dumb and ethically challenged! They have proven it over and over in many ways!