I shared to notes what I hope they do. A new P3 trial with the US that was either the same or just slightly shorter than the prior one to extend the washout and get a very high complete cure value.
Because again, the washout only needed to slightly longer and they would have smashed everything exists. Moberg Pharma looks like a disaster on the outside. The stock will get hammered for failing to reject the null hypothesis, but the people that think Amir is someone that's dumb are mistaken. He's a master and we are in his domain.
Bayer's a really giant company and this one doesn't move the needle for them. I don't really believe they care a lot about complete cure values because their OTC products don't really advertise that, and the market outcome in Sweden only signals positive things about market reception.
But for Moberg this product is everything. There's no way to ever know the truth of the matter because of what we're told is what we're told.
I'll hop onto the call to ask some questions. I'm definitely a little concerned about the first supplier qualifying. Not going to be mad at Anna or anyone else, this is just the series of events as they're going come. There's people that have waited over 12 years for this product to come out and I've only waited 2.
I am not sure how to reconcile that he is a master at play with the failed test, was this a desired outcome / overzealous attempt or is it just that hard to get significance with 1% terbafine?
He was the lab director of Novartis when lamisil was made and is in part reaponsible for 2 of the major nail topicals that even exists. This guy is as heavy as it gets for this class of pharmaceuticals.
Thinking Amir doesnt know what he's doing just because Moberg Pharma looks like a fucking dumpster fire is peak narcissim.
a 10% terbinafine solution cannot be made OTC in America. The FDA has a vice grip on what percentage of antifungals are permissible to sell OTC, and our country is very strange about what antifungals you can sell without prescription in general. You can sell a 1% terbinafine solutions OTC. You can't sell a 10% terbinafine solution OTC. Cipher will hopefully be wise and buy the license for a seemingly free price. Moberg not wanting to risk the failure of another clinical trial will probably just replicate their previous trial or lengthen the washout period by a few weeks or so to step over the bar again and get a better complete cure value.
My understanding is that while there is no OTC monograph for anything over 1% terb but they can still submit an NDA to the FDA to go to market as OTC. Similar to Rx NDA application but with additional consumer studies
They could, but if Moberg wants to make money they'll register it RX because the pricing is better. And if they ever manage to get it here, strictly under a licensing agreement they would make way more money from a distributor selling less volume to RX. That's the simple fact of the matter situation; US RX pricing is way way better for them.
Great summary! Regardless of the outcome, the process here was near flawless - thank you for that.
I shared to notes what I hope they do. A new P3 trial with the US that was either the same or just slightly shorter than the prior one to extend the washout and get a very high complete cure value.
Because again, the washout only needed to slightly longer and they would have smashed everything exists. Moberg Pharma looks like a disaster on the outside. The stock will get hammered for failing to reject the null hypothesis, but the people that think Amir is someone that's dumb are mistaken. He's a master and we are in his domain.
Any thoughts on what unfolded with bayer? Why would they change their mind?
Bayer's a really giant company and this one doesn't move the needle for them. I don't really believe they care a lot about complete cure values because their OTC products don't really advertise that, and the market outcome in Sweden only signals positive things about market reception.
But for Moberg this product is everything. There's no way to ever know the truth of the matter because of what we're told is what we're told.
So the big questions for tomorrow’s call are:
1. What happened with bayer?
2. Are they doing another trial?
3. Supplier qualification?
I'll hop onto the call to ask some questions. I'm definitely a little concerned about the first supplier qualifying. Not going to be mad at Anna or anyone else, this is just the series of events as they're going come. There's people that have waited over 12 years for this product to come out and I've only waited 2.
I am not sure how to reconcile that he is a master at play with the failed test, was this a desired outcome / overzealous attempt or is it just that hard to get significance with 1% terbafine?
He was the lab director of Novartis when lamisil was made and is in part reaponsible for 2 of the major nail topicals that even exists. This guy is as heavy as it gets for this class of pharmaceuticals.
Thinking Amir doesnt know what he's doing just because Moberg Pharma looks like a fucking dumpster fire is peak narcissim.
So cipher could still get Us licensing rights and go rx instead of otc correct?
a 10% terbinafine solution cannot be made OTC in America. The FDA has a vice grip on what percentage of antifungals are permissible to sell OTC, and our country is very strange about what antifungals you can sell without prescription in general. You can sell a 1% terbinafine solutions OTC. You can't sell a 10% terbinafine solution OTC. Cipher will hopefully be wise and buy the license for a seemingly free price. Moberg not wanting to risk the failure of another clinical trial will probably just replicate their previous trial or lengthen the washout period by a few weeks or so to step over the bar again and get a better complete cure value.
My understanding is that while there is no OTC monograph for anything over 1% terb but they can still submit an NDA to the FDA to go to market as OTC. Similar to Rx NDA application but with additional consumer studies
They could, but if Moberg wants to make money they'll register it RX because the pricing is better. And if they ever manage to get it here, strictly under a licensing agreement they would make way more money from a distributor selling less volume to RX. That's the simple fact of the matter situation; US RX pricing is way way better for them.
Does it look like they will pursue that?