Apr. 5 at 12:52 AM
$VXRT
Let’s Get Real
Some folks are using AI to counter something that’s right in front of our eyes, spinning the Cocrystal news as anything other than potential bad news.
Facts:
1. Cocrystal is a direct competitor with an oral Noro pill that has been developed and is being marketed as a preventative and therapeutic. Their product is intended to prevent infection before and after exposure.
2. The FDA doesn’t hand out Fast Track status unless a drug has demonstrated potential. Fast Track status is earned, based on science.
3. Vaccines often don’t qualify for the same kinds of expedited pathways as antivirals because they involve more complex testing and longer observation periods.
4. Antiviral drugs act on the virus rather than the immune system, so their regulatory pathway is likely to be shorter than Vaxart, because vaccines require:
Immune Response Testing
Long-term Efficacy Studies
Broader Population Testing
In contrast, antiviral drugs are typically evaluated on how effectively they target and inhibit the virus directly, a process that can be more straightforward and shorter.
5. Antiviral approval is based on “mechanism of action,” so the clinical trial design and approval process for antivirals are usually quicker.
6. The fast-track process gives them a leg-up because they now have several potential timeline advantages, including accelerated development.
7. Cocrystal is eligible for a Rolling Review, so they can submit data as they collect it, accelerating the approval process.
8. If the drug shows strong results in clinical trials, it could be eligible for Priority Review, which further shortens timelines.
9. Antiviral drugs can sometimes receive an EUA if there’s a serious outbreak and no effective treatment exists. Vaccines can also be granted EUA, but they generally have more rigorous requirements and longer timelines for approval.
All this said, Cocrystal still has many hoops to still go through. Much work to be done. Nothing guaranteed. They could fail. It’s early.
And here’s the good news…
Antiviral treatments typically cost more to develop initially because they require chemical synthesis, clinical trials for safety and efficacy, more complex biologic production methods, and they can be more difficult to produce at scale.
Additionally, antivirals are sometimes priced higher because they target diseases in a therapeutic way, which can make them more valuable for managing outbreaks.
In contrast, vaccines typically have lower production costs than antivirals, particularly if they’re based on platform technologies.
Vaccines also often benefit from higher distribution volumes, which can lower per-dose costs.
Cocrystal’s price will also depend on whether it's priced similarly to other oral antivirals, which can range from
$200–
$500 or more for a course of treatment.
That last point is a massive advantage for us.
But all this said, I’m not discounting Cocrystal at this point, which is what I did two weeks ago before the news came out the other day.
All I'm saying is, it's smart to keep an eye on them.
