These are my latest musings on why I think Arena will get European approval. As usual, don't rely on these -- they're not investment or expert advice.
Also, at the bottom, a few videos I just edited.
As anticipation brews for a CHMP opinion I find myself consumed with the subject of European approval again... My gut feeling is positive and the reasons for it are:
These are all my interpretations / opinion :
- Arena answered 180 day questions -- EU needed outside experts to help it understand the complex data -- just as FDA needed an AdComm -- Arena worked with the CHMP and its experts along the way.
- What are the chances that these experts gave a green flag after examining the data? That was the purpose of my call to Dr. Daniel who knows this data better than anybody outside Arena. He confidently confirmed that a real expert looking at the data will see clearly that valvulopathy and cancer are not issues. Therefore, I'm confident safety is not a concern.
- In 2011 EMA approved a paediatric investigation plan for lorcaserin (which tells me something about safety).
- Lorcaserin meets EMA's categorical criterion of greater than 10% weight loss over placebo at the end of a 12 month period. As a friend just put it, we would not have gotten this far if efficacy was an issue.
- Obesity is an epidemic in most EU countries. They need Belviq and I don't see them having any good reason to reject it.
Correction: Arena has stated at various presentations that the results of a meta-analysis of Belviqs three phase III clinical data meet the EMAs current alternate primary endpoint criteria for weight loss. Also, that the applicable EMA guideline is in review, with the possibility of relaxing the 10% primary endpoint criteria in light of other health benefits and patient safety offered by the drug candidate. As a friend just put it, we would not have gotten this far if efficacy was an issue.
Other health benefits could be HbA1c numbers couldn;t it. Well these agencies use met-analyses to hock on drugs, so I guess this met-analyses if done must also be applicable to push them over the top to approval.
Personally I think any met analyses (including VVUS and/or ARNA is a more dubious way to evaluate drugs versus controlled clinical trials in their own right unless the patient populations are really similar. that doesnl;t always happen? But pooling for more confidence is an often used feature in drug development today!
As I have said---ARNA has a solid good chance in the EU though others are worried--more than I!
Sentiment: Strong Buy
Salaam Reza. Someone put a post earlier (you have here as well) that the EMA had ok'd testing for pediatric use. I think it's a green light to passage. JMHO. I saw somewhat similar with Acadia when they had folks continue with Pimavanserin treatment after their first trials failed. I somehow "think" they wouldn't ok these studies unless they felt somewhat comfortable with the safety. I think the PRAC analysis is just to review possibility of valvulopathy, prolactin levels and cancer. I see the odds more in favor of passage.
This is why Belviq will not be approved:
"The Committee noted that there was a high probability that, if approved, the medicine would not be used strictly for the intended patients. The applicant did propose measures to reduce this risk, but the measures were considered difficult to implement in practice."
This is from the EMA's rejection of Qsiva/Qsymia. Why is this relevant to Belviq you ask? Because CHMP went AGAINST the recommendation of its own scientific advisory committee recommendation to approve Qsymia. This quote demonstrates EMA is more concerned about the health risks to non-obese patients then they are about the health benefits for obese patients. That's a value, cultural, political judgment that transcends any rational argument FOR approval.
So while there are rational health arguments for Belviq's approval for the intended patient population that's NOT CHMPs focus of concern. They care more about the potential of non-obese population being injured then helping obese patients (who SHOULD "exercise more and eat healthy” in many members opinion/value judgment).
Disclaimer: I don't support CHMP line of thinking but I believe that's where they are at. Don't surprised if Belviq is rejected in a few days.
Tod you claimed to use Qysmia on your board without diet and exercise changes consistent with the development programs---so did others---I read the posts. You people were bragging about it! Yet you think the EU will cut themselves out of belviq use because some euros might not do their diet and exercise. God your a scientific fruitcake!
Sentiment: Strong Buy
I also have a lot of confidence in Craig Audet and the Arena team -- I think they're absolutely top notch and after what they've been through with the scrutiny at the FDA and 2 AdComm's they're experts at addressing any objections.
- If we delete corruption, anything other than science is cost -- what else? Belviq helps healthcare systems save a lot of money so the cost factor is also in our favor.
I am not worried about corruption -- as someone familiar with the process told me yesterday, it's harder to get EMA parties corrupted because they're disparate and spread out among multiple countries and co-rapporteur -- and also farther from some of the Wall Street cockroaches.
Its not about the freakin Drug. Its about a Criminal element that is in control of the DEA. The DEA will label and release Gasoline for Human Consumption if the right person tells them to. Accept that and you will sleep better at night.