Post by
MrMugsy on Oct 29, 2022 8:44am
2023 ...
All the longs thought we'd be well into Phase 2 trials by now - but - the company made what seemed to be an 11th hour change.
Let's step back a little further even ...
- first, adding a P2 Molar in November
- then, moved it to October
- once again, moved it to a September start
On August 15, their Q1 report indicated ... completed load dose pharmacokinetic/pharmacodynamic studies in the quarter; results suggest viable onset of action for acute pain relief.
Then Dan was ... "We're particularly excited to launch a Phase 2 molar extraction study next month, enabling us to collect data in post-operative patients for the first time.
But - we never got to Phase 2. Why?
Because, that was only half the story. There was another part of the story that was unknown - a part that the company couldn't discuss. All we knew ... if one asked ... was ... that the company was in a period of deep-deep science.
- there was liver science with outside Specialists
- there was prepatory work for 346 Acute
- there was 346 in an advanced formulation
- and - futher development work in IBD with 3 new candidates identified for IBD
- likely others too but we don't have the details
So, what is it about this new formulation that would get you to stop your Phase 2 plans ?
Something much better ?
All eyes on animal studies and any additional work before we go into Phase 2 Bunionectomy.
BTW, they don't call it a Phase 2 study anymore ... they call it an "enhanced" Phase 2 bunionectomy study. Is that word "enhanced" important ? We don't know.
What we do know ... is ... our shift to an advanced formulation offers ...
1. accelerated onset of action
2. significant dose reduction
3. an additional safety buffer (based on #2)
4. potential pathway to address chronic
So ...
#1 is great for acute.
#2 is very important for generating options for chronic.
#3 is just better drug design (if you can swing it.
#4 is potentially worth billions in sales if you can get there.
How would you ever say "NO" to an advanced formulation that offers ... get this ... a significant dose reduction compared to its current formulation ?
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Not only are we looking at a better path to P2 Acute - but - we now open a 3rd door to Chronic and with any luck, the 3rd door offers a quicker way to a P2 confirmatory and back on track for P3.
Sure ... still lots of risk.
But - It's all about creating options and reducing that risk.
This is a very critical time (Q4 2022 - Q1 2023) in unlocking value and locking-in a 346 direction.
Sure, we're looking at a safer run for Acute (which we didn't expect) - but also - it's about generating a better path to Chronic. IMO
With this formulation, we've added a third path to chronic.
We had two paths but both came with complexities in regimen design.
Manageable but not ideal.
The third path is much more elegant - but - it requires Mother Nature to play nice in terms of what we expect from her.
Will she play nice ? TBD
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