Breaking my own rule - leaving the +10% P/L day trade on the table to go long
Caught a lucky break on $Tonix Pharmaceuticals(TNXP.US$ and bought pre-market before the day's news. I will leave this post up either as a reminder to myself to save money by spending patience or a monument to my own stupidity 😀
Good news everyone! (I have a previous post going over approval terminology if that helps)
Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia
They basically just took a medication that has existed for decades as a pill - and made a version which dissolves under the tongue. It is not quite as simple as it sounds. That administration route means the drug is going to absorb much faster and have a different bioavailability than the pill in the gut, so it's a lot of optimizing in engineering.
They basically just took a medication that has existed for decades as a pill - and made a version which dissolves under the tongue. It is not quite as simple as it sounds. That administration route means the drug is going to absorb much faster and have a different bioavailability than the pill in the gut, so it's a lot of optimizing in engineering.
WIth an active ingredient that has been around forever, the FDA doesn't have to be as stringent on having Tonix's data show the drug is low risk. It will be mostly to show that a patient will end up getting an effective dose in the range already known to be safe. That means the NDA process goes much faster and costs a lot less.
It also means insurance companies can't rely on the classic "yet unproven" or "inadequate post-market data to show lack of adverse events" justifications to not cover the medication. There are also only 1-2 generic medications with FDA indication for fibromyalgia, so insurance companies can't delay by requiring patients to fail on a long list of medications before paying for it. That all means an unusually high sales volume right after hitting the market.
For comparison - before paying for a new major depressive disorder medication, insurance companies can require a patient to fail 4+ medications first. They can also require a patient to use each med for at least six weeks before it can be deemed a "failure" - so that's half a year for them to delay coverage / the patient to get fed up and stop trying new meds.
The fibromyalgia market is huge and growing. It is a disease that a doctor can't diagnose directly. It's a "diagnosis of exclusion" - which is doctor speak for "we tested for everything we can think of and it was all negative, so we are going to say you have this so we can stop looking." Given how poorly medicine understands chronic pain and nerve disorders currently, that "get out of ignorance free" card is used a lot.
Sadly it's also a "cover your ass" maneuver here in the US. The federal government/DEA went overkill on opioid prescription scrutiny in response to the abuse epidemic. This has caused many doctors to decide that treating severe pain for something you can't prove with a numerical test result or imaging simply isn't worth the career risk.
Doctors need a DEA license to prescribe any of the controlled substance medications, most of which aren't opioids (e.g. ADHD meds, benzodiazepines, etc). That license is often all or nothing. The DEA getting unhappy with a pain prescription can effectively tank a doctor's practice by leaving them unable to treat people who need non-opioid CS meds.
While fibromyalgia is extremely painful and often causes people to become physically disabled, it's not life-threatening and doctors can refuse to treat it. The only meds on the market for it are actually anti-seizure meds that have been repurposed after coincidental effects on pain were seen after release. The issue is those meds require very high dosages to get any pain relief and so a lot of people (myself included) have to stop them due to all the cognitive side effects before even working up to those high doses.
The clinical trial data is also extremely promising. This is definitely at least an A- grade compared to the average data quality most NDAs start with.
Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia - Drugs.com MedNews
The clinical trial data is also extremely promising. This is definitely at least an A- grade compared to the average data quality most NDAs start with.
Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia - Drugs.com MedNews
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Investing primarily in bio-tech and drug development; both big pharma for growth and start-ups for speculation
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阳光大头菜 : goal 1
Arrayfunction OP 阳光大头菜 : Sorry, I only know English and I don't think the idiom came across in translation. My bad