1. Moberg can't charge too much for the product if they want to stay competitive, as such, they don't want volume to reduce by too much.
2. If Moberg can achieve a result with CC and MC that gives a label which implies more is better, people will default to 48w regimen even though that's not required.
3. Moberg also wants to get their patent so they can protect the life of their asset for longer. To do so, they likely need to show better CC rate than prior trials, and MC that's comparable or still acceptable.
Hence, if they can set the primary endpoint with CC rate that they know they won't achieve with the new regimen but still achieve improvements over prior trials by a bit(which shouldn't be too hard given the 4.5% rate), then they can have their cake and eat it too.
If you look at the application, it kind of refers to a restoration of a normal correlation. P3058 is listed as an example and is the only terbinafine asset listed in the application.
Yeah, and if they get the patent, they get time to tweak the regimen and iterate on the product which can end up with higher MC and CC. Effectively monopolizing the market for decades.
I don't understand point 3. They need higher cc for patent extension...but they seem not to achieve it with the new regimen (of the current p3 trial)...
Does that mean you think they'll pursue another p3?
Might be wrong here but I think about it this way:
First P3 trial had 4.5% complete cure which is very low for 70% MC. Compare to other topical treatments, CC is usually 20-40% of the MC. Given, 70% MC, one would expect ~15-30% CC.
We know 4.5% is too low, without assuming ulterior motives, knowing that Moberg thinks the approach of loading phase followed by maintenance phase should reduce whitening while keeping MC high(i.e. close to oral level), the change the regimen makes sense.
Why take so much risk using 8w vs just go with 24w though? For the patent, they just need to beat the 4.5%, say 10% CC with 50% MC. That already show improvement and it is novel. From a trial perspective, it would still be below expectation though.
That's what I meant by point 3. But maybe Left meant something else.
Haha, still don't get it. What you are trying to say is: 1- failed trial can help patent case? 2- Moberg did know this trial will fail, so they can sell more?
Thanks for clarifying your thoughts in recent weeks. Please take the following as a constructive challenge to the update and also in the context of this being a paid subscription and as a result being held to a higher standard than would be done for a free blog.
If I were to summarise the old thesis it was "this product is so good that the shares are a multibagger, let's just hope management don't turn the investment from a 20x to a 5x". For further context, it was not long ago that you were publicly outing Anna on twitter as being either incompetent or evil when it comes to getting this product in front of diabetics (re ulcers). Since the 'bad' (term used to reflect market sentiment per the share price move) data release, the tone has changed to be more along the lines of Amir (who wasn't named centrally in the thesis before) is a very intelligent subject matter expert and people are wrong to doubt them. I hope you can appreciate this is quite a severe shift in the credit you're giving for management competence. What would you say to this? Why are you now prepared to give so much benefit of the doubt to management's savviness when it comes to maximising value (duration + avoid a volume drop off) for the asset?
on twitter I'm provocative for engagement. You should probably treat that as a mix of satire and reality. They spent a very long time on this. I don't think there's communication that's relevant to their decisions making it through to IR. If it was a private company, I think more would be getting said.
Thanks for the reply. I'd say your criticism of management hasn't just been twitter satire but has also featured on here, but I'm happy to drop that point.
All / most companies spend a lot of time on things. Sometimes they make mistakes / mess things up. Spending time on something doesn't mean it goes how you want it to. I'm unsure why management deserve more credit for competence now than they did before and think it's a fair challenge...
Also, why would being private help? The argument made has been they can't comment on things because it could impact the trial (and any potential further patent) which isn't a public company issue.
To play it back:
1. Moberg can't charge too much for the product if they want to stay competitive, as such, they don't want volume to reduce by too much.
2. If Moberg can achieve a result with CC and MC that gives a label which implies more is better, people will default to 48w regimen even though that's not required.
3. Moberg also wants to get their patent so they can protect the life of their asset for longer. To do so, they likely need to show better CC rate than prior trials, and MC that's comparable or still acceptable.
Hence, if they can set the primary endpoint with CC rate that they know they won't achieve with the new regimen but still achieve improvements over prior trials by a bit(which shouldn't be too hard given the 4.5% rate), then they can have their cake and eat it too.
If you look at the application, it kind of refers to a restoration of a normal correlation. P3058 is listed as an example and is the only terbinafine asset listed in the application.
Yeah, and if they get the patent, they get time to tweak the regimen and iterate on the product which can end up with higher MC and CC. Effectively monopolizing the market for decades.
Also note these arent self enforcing things, expect it to be challeneged.
Challenged*
It wont be plural, but yes..
I don't understand point 3. They need higher cc for patent extension...but they seem not to achieve it with the new regimen (of the current p3 trial)...
Does that mean you think they'll pursue another p3?
Might be wrong here but I think about it this way:
First P3 trial had 4.5% complete cure which is very low for 70% MC. Compare to other topical treatments, CC is usually 20-40% of the MC. Given, 70% MC, one would expect ~15-30% CC.
We know 4.5% is too low, without assuming ulterior motives, knowing that Moberg thinks the approach of loading phase followed by maintenance phase should reduce whitening while keeping MC high(i.e. close to oral level), the change the regimen makes sense.
Why take so much risk using 8w vs just go with 24w though? For the patent, they just need to beat the 4.5%, say 10% CC with 50% MC. That already show improvement and it is novel. From a trial perspective, it would still be below expectation though.
That's what I meant by point 3. But maybe Left meant something else.
I think we have it oldcookie.
I just hope they pick up your point on the patent and make a case for it - at this point is the best they can do and it would be a surprise.
sadly i have low expectations of the mgmt and i fear they just failed miserably on the trial design.
Thanks for your work on this.
Hope it can be a wonderful story to tell to our grandkids
Diabolical. Thank you for this.
Attempting to salavage that 48wk label value leads into this if preservation of volumes was on their minds...
Haha, still don't get it. What you are trying to say is: 1- failed trial can help patent case? 2- Moberg did know this trial will fail, so they can sell more?
Thanks for clarifying your thoughts in recent weeks. Please take the following as a constructive challenge to the update and also in the context of this being a paid subscription and as a result being held to a higher standard than would be done for a free blog.
If I were to summarise the old thesis it was "this product is so good that the shares are a multibagger, let's just hope management don't turn the investment from a 20x to a 5x". For further context, it was not long ago that you were publicly outing Anna on twitter as being either incompetent or evil when it comes to getting this product in front of diabetics (re ulcers). Since the 'bad' (term used to reflect market sentiment per the share price move) data release, the tone has changed to be more along the lines of Amir (who wasn't named centrally in the thesis before) is a very intelligent subject matter expert and people are wrong to doubt them. I hope you can appreciate this is quite a severe shift in the credit you're giving for management competence. What would you say to this? Why are you now prepared to give so much benefit of the doubt to management's savviness when it comes to maximising value (duration + avoid a volume drop off) for the asset?
on twitter I'm provocative for engagement. You should probably treat that as a mix of satire and reality. They spent a very long time on this. I don't think there's communication that's relevant to their decisions making it through to IR. If it was a private company, I think more would be getting said.
Thanks for the reply. I'd say your criticism of management hasn't just been twitter satire but has also featured on here, but I'm happy to drop that point.
All / most companies spend a lot of time on things. Sometimes they make mistakes / mess things up. Spending time on something doesn't mean it goes how you want it to. I'm unsure why management deserve more credit for competence now than they did before and think it's a fair challenge...
Also, why would being private help? The argument made has been they can't comment on things because it could impact the trial (and any potential further patent) which isn't a public company issue.
because then they could tell you everything they are thinking.