GREY:ATBPF - Post by User
Comment by
MrMugsyon Oct 12, 2022 7:12pm
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Post# 35020960
RE:RE:RE:Don't fool yourself ...
RE:RE:RE:Don't fool yourself ...Wriggles wrote: MrMugsy wrote: MrMugsy wrote: The market isn't going to understand the full value of what's going on here - IMO.
They're going to need analysts to explain it to them. Hahaha !
Everything is back on the table - in a big way (it seems).
This is why it's been hard to get information out of these guys.
Lots of science on the go and they can't talk about it until a patent is issued.
As I've been saying - even the commercial study is going to be wrong - the numbers will be too low for the potential of this drug going forward (IMO).
If I am to guess, I'd say we're moving to a (higher purity) Naproxen - only a guess. There are other potential ways but I'd assume they come with greater testing requirements. To be seen.
I think this also puts 352 in question as well - might be able to do double duty if we're lucky. TBD.
Good Luck !
One potential direction as I've followed in the recent past (but there are others too) ...
"...we evaluated the efficacy of a new H2S-releasing derivative of naproxen, named naproxen-4-hydroxybenzodithioate (naproxen-HBTA), in reducing metastatic melanoma features, both in vitro and in vivo. The novel H2S donor has been prepared following a synthetic scheme that provided high yields and purity." With faster onset, might put peri-op on the map.
Already chasing Post-op and other acute indications.
Chronic back in the mix (but we don't know to what degree).
Assuming the drug is successful ...
Best case ... $60 BB+ market - post-op, other acute, chronic and peri-op
Worst case ... $25 BB with the acute markets as previously indicated
The decision to go with a new formulation could be as simple as comparing a few options in parallel and letting the winner take all.
The market(s) range could be anywhere between $25 BB and $60 BB+.
Sure hope that's the case.
Sure - this news has scared a few into selling - as I expected this AM.
Wouldn't take much to drop the price on a market sell.
So be it - came in handy for those who were ready to pull the trigger.
Now we need a bettter explanation as to what is really going on here - away from all the guessing - and - into some good understanding of what we're dealing with.
https://clinmedjournals.org/articles/ijmnr/international-journal-of-medical-nano-research-ijmnr-5-023.php
I would expect the new chemical formulation to be similar to the original, otherwise, past study/trial results might not be acceptable for NDA purposes.
From the NR:
“Over the summer, we made significant advances with a faster-dissolving formulation that we’ve been investigating since late last year...
The new formulation’s benefits include: (i) rapid dissolution mechanics, accelerating otenaproxesul’s onset of action, a key benchmark for acute pain medications; and (ii) enhanced bioavailability, enabling a significant dose reduction compared to its current formulation."
One possible method to increase the absorption rate of naproxen/OTEN is through the use of nanotechnology as described in the link:
"Larger the surface area, higher will be the dissolution rate. Since the surface area increases with decreasing particle size, which can be accomplished by conventional methods like trituration, grinding, ball milling, fluid energy micronization, salt formation and controlled precipitation. Although these conventional methods have been used commonly to increase dissolution rate of drug, there are practical limitation with these techniques as the desired bioavailability enhancement may not always be achieved. Therefore, formulation approaches are being explored to enhance bioavailability of poorly soluble drugs. Some such formulation approaches that have been shown to significantly enhance absorption of such drugs is to formulate nanosuspensions.
ATE is collaborating on new formulations with an American chemist whose specialty is believed to be nanotechnology.
Maybe there is a connection....
Yes - well said Wriggles
The more and more we think about it, the smaller the change must be - in order to continue from here.
I know of the partner you are talking - certainlly his interest is in synthetic design.
There are a number of ways to attack and the one you mention is very realistic in this situation.
Fingers crossed that it is a small change with large benefits to the drug.