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This new rule is interesting.
https://www.dea.gov/sites/default/files/2023-11/Quota-Shortages%20Letter.pdf
How should we interpret this new rule in the context of our supply agreement with Dexcel to sell Adderall in Israel and Palestinian Authority Territory. Let's say hypothetically when we do our new quarterly quota report to DEA it says we sent 25% of our quota to Israel. Does that mean they will grant us "replacement" quota for U.S. distribution to "Americans"?
https://contracts.justia.com/companies/elite-pharmaceuticals-inc-1799/contract/245031/
Looking for a reason to buy this stock?
This graph is fascinating:
While the number of prescriptions for stimulants increased by 45% from 2012-2021, the number of prescriptions written by physicians did not change much during that time period. Almost the entirety of the increase in prescriptions for stimulants was driven by nurse practitioners, and a significant number went to women age 31-40. I have a few ideas why that is, but they're beyond the scope of this post. I think this is important because in the future there will be many more NP's. It's easy to see around the country, as physicians burn out or retire, they are replaced with several NP's. Absent unforeseen events, I expect all of these trends to continue. More NP's=more stimulant Rx's, with young women continuing to be the fastest growing demographic.
The whole report is short and worth the read. Some good bits in there.
https://www.deadiversion.usdoj.gov/pubs/docs/IQVIA_Report_on_Stimulant_Trends_from_2012-2021.pdf
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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
Isradipine continues to prove it's an interesting molecule.
Interesting, but not (yet) lucrative.
https://pubmed.ncbi.nlm.nih.gov/37698934/
JCI Insight. 2023 Sep 12;e162468. doi: 10.1172/jci.insight.162468. Online ahead of print.
This post has a lot to unpack.
This is happening...
***Epic is the distributor for Elite's isradipine. If Epic has discontinued our isradipine, then I presume it is in preparation for the move to Elite's own label. Also interesting is that there are only 2 active ANDA's for isradipine, and they are both currently unavailable. Hopefully that situation will be resolved soon, otherwise a lot of long term users will permanently switch to other drugs.
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Pure, unadulterated speculation... Siklos (hydroxyurea)
Hydroxyurea is an antimetabolite that is effective and FDA-approved for treatment of many conditions, including acute myeloid leukemia (cytoreduction), chronic myeloid leukemia, essential thrombocythemia (high-risk), head and neck cancer, hypereosinophilic syndrome (refractory), meningioma, polycythemia vera (high-risk), and sickle cell disease. It is sometimes used off-label for psoriasis. Brand name Droxia is supplied as 200mg, 300mg, and 400mg capsules. Brand name Hydrea is supplied as 500mg capsules. Most prescriptions are for the only generic form, which is a 500mg capsule. All forms, especially generic, have long been prescribed for sickle cell disease (SCD), although neither Droxia or Hydrea ever had SCD listed as an indication on the FDA-approved drug label. In 2017, Siklos (dissolving hydroxyurea tablet) was approved for pediatric SCD, and later it was also approved for adult SCD. Siklos was originally approved with pediatric exclusivity that ends 12/21/24, per the Orange Book. A supply of generic hydroxyurea 500mg capsule (2 per day) would cost ~$20/month, while brand name Siklos retails at $1900/month. All forms of hydroxyurea have two black box warnings on the label for bone marrow suppression and secondary malignancy, and there are a plethora of other potential, serious complications. Nasty stuff, always must be handled with impermeable gloves.
There seems to be at least one major advantage of the tablet over the capsule:
"Should've Said No" by Taylor Swift