Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Fun facts for the Reality-Based Community:

1. For the federal government in general and the FDA specifically, the words they use have a precise meaning. Lucky for us, they are required by law to explain to us exactly how they are using these words. For best results on the interpretation of FDA language, I recommend referring to the "Federal Register" and avoiding "E-mails From Dianne."

2. When the FDA considers an ANDA application substantially complete, then it is received. Once the application is received, then the review period begins. If an application has not been received, then it is not considered substantially complete, and the review period has not started. As usual, my bullshit comes with links (beware the poster who demands links but never provides any).

https://www.federalregister.gov/documents/2021/05/03/2021-09134/withdrawal-of-notice-regarding-the-food-and-drug-administration-drug-review-timeline-transparency

The Statement of Policy did not accurately account for the time that the review period for drug applications starts. Although the table of drug approvals presented in the Statement of Policy (86 FR 4083 at 4083–4084) references the drug application submission date as the beginning of a 180-day review period, the review period does not actually start until a drug application is “filed” or “received” by FDA (see section 505(c)(1) and (j)(5)(A) of the FD&C Act (21 U.S.C. 355(c)(1) and (j)(5)(A))). ...... An ANDA is not received until FDA has made a threshold determination that the ANDA is substantially complete (§?314.101(b)(1)). If the ANDA is received, the date of receipt is then considered to be the date of submission (§?314.101(b)(2)).

3. IQVIA is a reliable source. The I-box on this page is not a reliable source. If anyone has access to true IQVIA OxyContin numbers, please post them. The $720M figure referenced in the I-box on this page is solely based on a PR that does not mention OxyContin. That is not a proper citation, and there is no other known source of this number, so if anyone found an outside source that references 2022 OxyContin sales, then I would appreciate if they posted it. For example, here's an outside link that shows generic Norco sales in $700M range. Similar numbers are reported in various Elite Pharma Annual Reports. You can look those up yourself.

https://www.lupin.com/lupin-launches-generic-norco-tablets-in-the-us/

Hydrocodone Bitartrate and Acetaminophen tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg had annual sales of approximately USD 710 million (IMS MAT Jun 2017).

4. In the not distant future, all my babies will be out of the house and living on some college campus somewhere. This fact causes me much greater stress and anxiety than any of my bone-headed investment decisions. Their health and happiness is worth far more to me than any investment- past, present, future. I make a point of discussing this with my patients who are young fathers. I tell them their employer will never, ever tell them they are spending too much time and energy on their work. I tell them their children do not give a rat's ass how much money they make. I tell them their children will only remember the time they spend with them, both good and bad. I tell them that some of the earliest memories of my own children are that I was working in the hospital on Christmas, and I really regret it. (BTW, this is true of ALL hospital workers. As a physician, I only had to work every other year, but many hospital employees-- nurses, patient and lab techs, housekeeping and maintenance, cafeteria and food service workers-- do not enjoy the same luxury. Whoever you know in that situation, appreciate them for this sacrifice, it is for real.) Young fathers in the Reality-Based Community, take heed. The priority you give to your family is not something you get to go back and fix later on. Don't wait your whole life for your ship to come in while the real treasure is sitting on the couch watching Family Guy reruns.

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