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This is potentially enormous. Rayaldee=extended release calcifediol.
https://www.renalandurologynews.com/home/news/nephrology/secondary-hyperparathyroidism/excessive-body-weight-lessens-the-efficacy-of-vitamin-d-supplements/
Makes sense. Such an interesting delivery system. Something to keep an eye on. TY!
Hi JTFM-
Wouldn't it make sense that Halozyme would want the libigel IP? Their CEO stated on conference call that further acquisitions related to endocrinology would be in line with company goals. They are soon to hold an impressive testosterone pipeline.
It's a gel in a metal canister that dispenses exactly 300 mcg of T. It's applied directly to skin and then hands are washed. Intrinsa is the same basic thing on a patch that is discarded after a few days.
Libigel is a gel. Intrinsa is basically Libigel on a band-aid.
JTFM and BB-
I agree that the CVRs ever paying out is highly unlikely. I also agree that Intrinsa patches advancing with our safety data is a real possibility. The transmission of testosterone to others was a big factor discussed early on (even though the dosage is ridiculously small) and the patch will be seen as safer. Intrinsa also has an actual customer history elsewhere.
JTFM-So exciting! What a day! Thanks for sharing all your research.
Congratulations to all board members! What a comeback! Thank you to all contributors.We may hit $60 today.
Remember that our CEO is new(ish). Established reputation but not with ANI. Trust is built.
Pandemic related supply issues are real and everywhere.
Minnesota has had a huge spike in covid cases since Labor Day.
I don't believe the FDA is incentivized to block a Mallinckrodt competitor and I don't think the opioid/tobacco analogy is a thing. Tobacco receives agriculture subsidies while these opioids are lab grown, and far more dangerous to youth.
Patience. We have a history of recovery and exciting, fast, pps growth once we're lit.
Thumbs up emoji
US political discussions are divisive, now more than ever. I do not support allowing them on this forum unless they are DIRECTLY relevant to ANIP. We run the risk of alienating important contributors (RG makes the short list).
I have been here a long time although not a frequent contributor as of late and yes, I migrated here from Yahoo because of toxicity. Thank you.
RG- Thanks for the great explanation.
Perhaps not a complicated molecule but very difficult for women to access because docs are reluctant to write scripts for compounded products, not FDA approved.
I feel the time is right for this product. Young transgender people are transitioning to male and getting access to T at a growing rate. Hard to justify denying postmenopausal women a script for a comparatively miniscule amount of T to help restore normal sexual function. JMO.
Testosterone is a controlled substance. Even if it is advertised online, no one is accessing it without script.
1. Scream cream does not contain T. On-line ingredients list sildenafil. Script most likely needed in USA. All T products require script.
2. Libigel flunked efficacy by being not superior to placebo. Libigel passed safety. P&G attempted to get approval for Intrinsa (basically identical to Libigel) and ironically passed efficacy but flunked safety. They have successful efficacy data (but used concomitant estrogen in trial). JTFM, correct me if I'm not recalling correctly.
3.correct.
Key opinion leaders feel that research and testing has been conducted ad naseum. Hence, the global position. Compounded products are an obnoxious paperwork layer for OB/GYN professionals and patients alike producing an inferior product that often requires mail/fed ex delivery because of the scarcity of compounding pharmacies. The 4 million compounded T script figure that was cited a decade ago has likely tripled.
At the all-virtual CEU 2021 in September, two contributors to a global consensus statement, Susan R. Davis, MBBS, FRACP, and Margaret E. Wierman, MD, will describe the use — and misuse — of giving women testosterone.
https://endocrinenews.endocrine.org/ceu-2021-preview-does-testosterone-therapy-have-a-place-in-treating-women/
Yes! Since we already own the NDA. For those (like myself) who had forgotten about that: https://www.pharmaceutical-technology.com/news/newsani-pharma-buy-mercks-two-ndas-75m-4675497
Testosterone may prevent stomach inflammation and stomach cancer in women.
https://www.sciencedaily.com/releases/2021/05/210512142846.htm
Thanks JTFM
From the article: "T therapy has been increasing 12× worldwide since year 2000."
Great information Silvr! Thank you! Continued reliance on a compounded product for a treatment so broadly used is preposterous. Change is obviously happening!
Got somebody's attention! Too funny.
Susan Davis can spend a career demonstrating the positive effects of testosterone on women's sexual health but when those same women show improvements in their ability to parallel park, now that's a game changer! Lol, thanks for that!
Yes,of course.The link from post #12557 that states in sentence #2,"This is an amazing story of a patriarchal medical system that gives access of testosterone and viagra to men, but cannot approve small amounts of testosterone for women; cultural norms and delays in acknowledging that women’s sexual issues matter; and the financial forces involved to create and give access of useful products for women."
Suggesting hyaluronic acid, what exactly is your point?
Does sildenafil alone solve the health issues for a male who is testosterone deficient?
Many companies make hyaluronic acid women's "products." Some women buy hyaluronic acid powder and make their own.
No script required. No FDA approval needed. NOT a substitute for testosterone in the cases of hormone deficiency.
HSDD=hypoactive sexual desire disorder
I wonder is companies are ever paid to abandon IP? Strange in this new global position climate.
Thank you RG.
...or Instrinsa could seek approval with our safety data.
Thanks Slvr. Gene therapy is huge. You could be right!
RG- I had the same experience when I called to see if we were part of the ranitidine recall. My call was intercepted by a firm ANI had outsourced. Could not answer the Q. Thanks.
Although it may not amount to a huge revenue increase, it would not surprise me to learn that entities with access have been stockpiling fenofibrate. A Wisconsin congressman was promoting it. Other potential Covid-19 remedies and PPE have been amassed. Hoarders gonna hoard. https://grothman.house.gov/news/documentsingle.aspx?DocumentID=1669
Brilliant.
Same here!
I guess it's our perpetual optimism BB! Also keeps us in the snow belt lol! Best wishes to you!
No one has mentioned the recent filing involving Blackrock. Any thoughts? Thank you in advance.