They rejected Eisai request for the waving the 30 days so they could get on the market quickly.
And that my friends confirms the games being played in my opinion.
Arena and Eisai should demand an explanation why it took so long to make their final decision and why they cannot grant the 30 day waiver. The people in the DEA could be in cahoots with hedge funds and shorties
in manipulating Arena stock for almost a year since Belviq was approved by the FDA. Some people in the
DEA office who are on the Belviq desicion making process could be in the payoff with the hedgies. This has been going on in WALL STREET for so long and only and handful are in jail.
"DEA believes that the clinical indications for lorcaserin do not support the waiver of the 30-day period."
OK well lets look at some statistics comparing the potential drug abuser base that the DEA/HHS are seeking to protect with the denied waiver versus law-abiding patients seeking treatment:
The quotes/statistics below are from the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration.
"In 2010, an estimated 22.6 million Americans aged 12 or older were current illicit drug users, meaning they had used an illicit drug during the month prior to the survey interview. This estimate represents 8.9 percent of the population aged 12 or older. Illicit drugs include marijuana/hashish, cocaine (including crack), heroin, hallucinogens, inhalants, or prescription-type psychotherapeutics used nonmedically."
"Illicit drugs with the highest levels of past-year dependence or abuse were marijuana (an estimated 4.5 million people), pain relievers (1.9 million), and cocaine (1 million)."
Of this, marijuana users accounted for 17.4 million people!
Shockingly and defying logic, at this present moment it is far, far easier to acquire any of the aforementioned illicit drugs than it is for a doctor/patient to obtain Belviq; an FDA approved medicine.
We can also come to the conclusion that similarly defies common sense and basic logic - the DEA is delaying the potential treatment of up to 150 million patients to reduce the "potential" abuse by a user base that is at most 1/6th the size!!!
Sentiment: Strong Buy
I was disappointed to see that they didn't waive the 30 days wait too but I am just relieved that this regulatory phase is over. The 30 days may even be good (in a way). The stock may rise more in anticipation of sales- We won't have any worries of what the prescription counts are for awhile.
Sentiment: Strong Buy
Posting their justification and it really #$%$ me off.
regard to the comment about lack of abuse potential for lorcaserin, as mentioned in both HHS’
and DEA’s scientific and medical analyses, the data collectively suggest that lorcaserin does
have sufficient abuse potential and though the effective dates for scheduling zopiclone,
pregabalin, and ezogabine were the date of publication of their respective Final Rule, DEA does
not agree that lorcaserin’s effective date should be the date of publication of the Final Rule. The
clinical indications of above referenced drugs are different from that of lorcaserin. DEA believes
that the clinical indications for lorcaserin do not support the waiver of the 30-day period. With
regard to the availability of weight-loss drugs, DEA further notes that other weight-loss drugs are
currently available on the market.
What a crock of crappppoooolllaaaa
Because Qsymia is in the market they don't need to waive the 30 days, drugs are available for weight loss. That is a punch in the stomach, take the less safe drug with risks if you can't wait is what they are saying.