Let me first introduce myself, my name is Erik and I am an emergency medicine doctor. As of several years ago I decided to go into bariatrics (weightloss), and went through the american society of bariatric physicians to get my board certification. I have had my own practice open now for approximately 1 year, and partnered with another physician that has been doing this for 7 years. I want to help investors understand some of the studies that have been done, as well as convey my experiences as a specialist in an office based weightloss practice.
I first learned about Lorqess several years ago and have been following it since. As a physician I have spent countless hours researching this stock. In fact I have probably driven my wife mad doing my due diligence, pulling up articles, researching statistics, and so on. When I have a question I have access to several brilliant specialists (many of them are close friends) , which gives me an advantage over many investors.
This is my take on past and current events:
1. The echo studies done may show a small statistical increase in the chance of developing a valvulopathy, therefore post-approval echo studies will probably be required. This takes time depending on how they arrange it.....but I would assume they would be done at 3,6,9, and 12 months......so you are looking at at least 15 months out from approval before the results are submitted back to the FDA post-approval.....
2. Developing cancer from this drug is not a side effect until you go 80x the normal dose!!! however there is a small chance of developing a fibroadenoma, which is a begin breast tumor.
3. I think the potential to have the DEA schedule the drug is there. If it happens most likely it will be a schedule IV, which means an abuse potential is there. However, the studies that Arena did with 40-60mg did not indicate that....but what happens when you go past dose. Lorqess is dosed 10mg twice a day. At this dose there may be some mild cognitive problems, or psychological changes (which can occur in almost all drugs on the market that affect the brain,ie antidepressants...etc) in a small % or patients. At higher doses, there maybe abuse potential....however, I know a number of abused drugs that are not scheduled with the DEA.Remember Arena developed the drug to have specificity to the 5HT2-C receptor (the appetite control center in the hypothalamus), and not the 5HT2-A (this functions in he other parts of the brain and may cause the psychological side effects. If it does become a scheduled drug, it may decrease Arena's overall profit, but I speculate by only a small amount because the vast majority of physicians have a DEA license and will be able to prescribe this.I believe the abuse potential is theoretical, but will not stop approval. I also believe there is a small chance it will be a scheduled drug because of the theoritical abuse, but the studies at double prescribed dose did not show abuse potential.
Overall comments are positive.... however, Number 2 is not correct.... SD rats are inherently susceptible to this.
Post marketing data will prove this out, imo.
I defer to DrDaniel's thorough notes on this:
Good article. My wife and daughter are also tired of me ranting and raving about Arena and Lorcaserin, and my frustration with the food industry selling almost every prepared food with high fructose corn syrup. BUT NOW...they're happy with my paper profits after all my original investment has been paid for.
If what you writing true (About risk of cancer and tumor) why 3 out 4 tox/pathologist voted No ( also 3 out 4 "No Vote) from them)
FDA will give higher weight to those Vote over other. Many hardly able to make mind to Yes Vote.
I know you might be right, but FDA likely take no risk and so it has to go though another trial phase before it get approve and that mean more 100's million share will be issued.
First thing is to define what type of toxicologist they are. I did my toxicology rotation at Cook County hospital in Chicago. Most tox guys deal with acute overdoses and the treatment of them, ie...when you call poison control there is always a tox doing his fellowship on standby for complicated polysubstance overdoses to talk to. I would be more inclined to discuss Lorqess with a pharm-tox that deal with carcinogenicity of drugs than the former.....these would be research tox spealists, and they are few and far between.
Second, I agree in high doses this drug causes cancer in rats.....but so does aspartame...ring a bell...its Nutrasweet. So should you stop drinking diet coke?!!!!! Both have been proven to do so. Every drug has a risk, and so you have to look at the risk/benefit profile. Fortunately, the FDA has set a rigid guideline for approval of these potential carcinogenic drugs....and that is 24x the prescribed dose. Lorqess surpasses this standard, so once again, there is no reason to not approve based on their own set standards!
Finally, if we voted all the drugs based the their 'potential' to cause side effects, there would not be any drugs on the market. All drugs have side effect.....I have seen people die from tylenol and aspirin overdoses. This is not a reason to take them off the market!!! Ultimately, it is the doctors job to weigh the risks and decide what patient this would benefit from this drug. If you still disagree with me after these facts, than we can agree to disagree.....but if you have not done your DD, and just listen to the average joe posting on this board, then you are due for a loss if you are shorting this stock and I am sorry....Erik
Timing of your message question your motives. Anyway, for last several years and twice in ADCOM, industry experts , doctors, pathology group etc have reviewed this drug and results.
Thanks for your opinion but keep it to you because in the area of medicine I personall value grey hair opinions rather than infants - no offense. Just my choice.
BTW - Are you long? if yes, then why and if no then I don't listen to -ves at the 11th hour.
My motive is to uphold my oath, "First do no harm", and to provide care to my patients that will improve their quality of life. I am a patient advocate first! I did not spend 12 years in school, to put my patients on a medication that would harm them. I believe this drug will improve the quality of life for many of my patients.
To be honest time.....I have read the posts from Dr Dan, and monitored the posts with 4-5 star ratings. Like most physicians, I am guilty of working too much at the sacrifice of spending time with my family......so something has got to give....There is alot of good information on the message board, but weeding through it is cumbersome. I have posted the 2 messages because I saw the stock plummet this morning. I wanted to give my input, since it was long overdue.....it was time for me to give back. I am in a unique position, because unlike many of the other doctors on here, one of my practices revolves around the use of these drugs. I am also a E.R. doctor, so by definition 'I know alittle about alot".