Is Gilead Holding Back Data on Inhaled Remdesivir?

Disclaimer: This post does not constitute financial or medical advice. Author has a long position in Gilead. Do your own due diligence before making an investment.

Yesterday after the market closed, Gilead announced that they halted their phase 3 trial of remdesivir in intravenous high risk non-hospitalized patients.

They say this is not due to efficacy or safety.

I believe them.

(Next two quoted paragraphs are from their official company statement.)

“The primary unmet need for non-hospitalized patients with COVID-19 is for effective and convenient therapies that can be easily administered at home.”

Remdesivir is an anti-viral. It works like this:

Imagine Covid-19 is both gasoline and a fire. Remdesivir is like a magic spell that grants you immunity to fire (sort of.)

If someone were to douse you in gasoline and light you on fire, then you would have to cast Immunity to Fire very quickly so that you don’t die.

That’s the problem with intravenous remdesivir. It’s too slow. If you’ve already suffered massive burns to your body, then how much good is becoming immune to fire? Well, a double-blinded, placebo-controlled study shows that it saves you about five days in the hospital.

That’s not good enough.

But that’s remdesivir classic. Gilead is working on much better spells.

“Gilead remains committed to developing treatment options for non-hospitalized patients with COVID-19 that address this need. We continue to develop investigational inhaled dosage forms of remdesivir and novel oral antivirals, with the goal of delivering effective, well-tolerated and significantly more convenient treatment options for patients.”

They mention two things here, oral, and inhaled. The inhaled version is an in-house project. The only oral version we’re aware of is being worked on by Matinas BioPharma. ($MTNB)

These would be much better spells. Intravenous is slow. Intravenous requires hospitalization, a clinic, or at least a nurse. To get remdesivir in a hospital you need to A) Get Covid-19, and B) Be affected so badly by it you need to be hospitalized.

This is insane. People often rag on remdesivir, but of course it doesn’t work amazingly when it’s intravenous. It’s an anti-viral. It prevents viral replication. A fire extinguisher is a similar device. It prevents fire replication.

Imagine a neighbor knocked on your door. You open it to find that they’re suffering from third degree burns and nearly dead. They ask you to use their fire extinguisher on them.

Like…what? That’s ridiculous. But that’s the current form of remdesivir.

Inhaled remdesivir, administered through something like an asthma puffer would be fast. Swallowing a pill might be even faster.

This would be like casting Immunity to Fire on yourself after discovering your shoe is on fire. Sure, you might scorch your toes, but that’s a lot better than burning alive like one of those monks in Vietnam.

Here are some facts:

The original intravenous remdesivir trial took 96 days. [Start][Finish]

The CEO of Gilead told CNBC: “We fully expect remdesivir to be effective against these new strains.” He also added, “Remdesivir works at the source in the cell where the virus replicates, and what we know is in these new variants, that part of the cell is not changing at all in fact.” [Source]

The inhaled remdesivir trial was initiated 279 days ago and officially started 211 days ago. Results have not yet been posted. [Initiated][Start/Finish]

On April 9th, the inhaled remdesivir trial phase 1/2 trial on ClinicalTrials.gov was updated to completed. [Source]

Gilead stopped an intravenous phase 3 trial because have decided to focus on alternative formulations (inhaled and oral.) [Source]

Last weekend, due to their worsening Covid-19 crisis, India suspended the export of Remdesivir and associated APIs (active pharmaceutical ingredients.) [Source]

Something in India is causing people to test negative for Covid-19, even with the highest quality of test (RT-PCR). [Source]

Last weekend, the head of the Chinese CDC admitted that efficacy of the Chinese vaccine was “not high.” [Source]

(I’ve read that in China, saying something is “not high” is the polite way of saying it’s low.)

Here is some speculation: (NOT EVIDENCE AND THERE IS NO PROOF OF THIS.)

1. Gilead has the data on their inhaled remdesivir study. They know it works, possibly to the level where it’s a “silver bullet.”

2.  Gilead is aware that vaccines are not going to be a great solution due to mutations and fading antibodies.

3. There isn’t enough supply of remdesivir, so Gilead is delaying the inhaled results until there’s enough supply to around. Or maybe at least until India reallows the export of remdesivir and associated active pharmaceutical ingredients.

(The above three points were speculation. I have no proof of this, only loose evidence that comes from connecting the dots.)

If Gilead has information that could save lives, it has a moral and ethical responsibility to release this information immediately.

If Gilead is unable to produce enough inhaled remdesivir to meet demand, then they should say so. License the technology. Give away the IP. Do whatever it takes to put an end to this mess.

While I am a Gilead investor, I would gladly forsake all inhaled remdesivir profits to put an end to this pandemic.

If inhaled/oral remdesivir is the silver bullet to ending the Covid-19 pandemic, then the world has a right to know.

Gilead might be holding this information back because they’ve assessed the supply chain and determined that nothing short of an act of God will bring manufacturing up to speed quickly enough to prevent millions of deaths.

But humans are a resilient species. When we work together, we’re very good at solving problems. At the beginning of the pandemic, Gilead was able to reduce the manufacturing process of remdesivir from 1 year to 6-8 months. What if somewhere out there is a kid in a dorm room who can bring it from 6 months to 3 months?

Maybe some retired chemist can figure out a way to replace one of the complicated ingredients with something more readily available.

This is not time travel. This is not impossible.

Millions of people working together to drastically speed up the production and distribution of inhaled or oral remdesivir is theoretically do-able.

In 1939, George Dantzig, a student at the University of California, arrived late to statistics class. On the chalk board were two “unsolvable problems.” Thinking they were homework, George copied them down. A few days later he handed in the solution to one of the problems and apologized to his professor for taking so long.

Six weeks later, there was a loud banging on George’s door. It was his professor. He was there to say that George had solved one of the unsolvable problems.

George had solved it because he was never told it was impossible. He just kept working on it until it was finished.

So.

When anyone tells you something is impossible, you should ask them if it violates the laws of physics. If it does not, then you should politely ask them to go away and let you work.

Gilead has less than 12,000 employees. Earth has more than seven billion people who would like this pandemic to be over.

If supply is the problem, Gilead should ask for help before it’s too late. Maybe there’s another George Dantzig out there. Someone that can save us from this slow-rolling apocalypse.