|
|
Post by neil36 on Jan 25, 2023 22:05:55 GMT -5
|
|
|
|
Post by neil36 on Jan 25, 2023 22:09:41 GMT -5
|
|
|
|
Post by Thundersnow on Jan 26, 2023 10:04:08 GMT -5
Will MNKD find a partner for Clofazimine? I don't think so. The ONLY player is Novartis and I don't see them wanting to get back into this market. I see Mike going SOLO.
It's not like Novartis is currently marketing this drug. I also think Mike knows the value of owning your own drug.
Q: Will there be any ownership/patent issues with Novartis?? This drug was resurrected by Hoffman so I'm wondering if there will be a legal battle of the rights?
|
|
|
|
Post by derekewhitlock on Jan 26, 2023 10:09:32 GMT -5
I have been unable to find a projected timeline to the II/III Clofazimine studies. Does anyone have any guidance/educated guess on the expected time frame? Thank you,
|
|
|
|
Post by mango on Jan 26, 2023 17:02:05 GMT -5
I have been unable to find a projected timeline to the II/III Clofazimine studies. Does anyone have any guidance/educated guess on the expected time frame? Thank you, I think it’s within 60 days (not 100% sure). Not sure how long the timeline for their adaptive Phase 2/3 clinical trial is though. |
|
|
|
Post by radgray68 on Jan 26, 2023 20:33:56 GMT -5
28 days on the drug, two months off, then another 28 days on, then two months off. So, 6 months. As for how soon we can get the trial set up, could take several months yet.
|
|
|
|
Post by mango on Jan 27, 2023 6:35:13 GMT -5
28 days on the drug, two months off, then another 28 days on, then two months off. So, 6 months. As for how soon we can get the trial set up, could take several months yet. I’m guessing we will see approval sometime next year then. We have a lot of big developments going on right now. Clofazimine Phase 2/3 Afrezza Peds Phase 3 Afrezza India Phase 3 Afrezza pump switch trial Phase 4 Multiple pipeline assets continuing to progress Mike said 4 IND subs within next 24 months |
|
|
|
Post by prcgorman2 on Jan 27, 2023 7:39:36 GMT -5
28 days on the drug, two months off, then another 28 days on, then two months off. So, 6 months. As for how soon we can get the trial set up, could take several months yet. I’m guessing we will see approval sometime next year then. We have a lot of big developments going on right now. Clofazimine Phase 2/3 Afrezza Peds Phase 3 Afrezza India Phase 3 Afrezza pump switch trial Phase 4 Multiple pipeline assets continuing to progress Mike said 4 IND subs within next 24 months I always appreciate your reminders of on-going efforts to build the Mannkind product bench. Thank you mango. I’m eager for the 4th revenue pillar. I’m excited that 2023 should see Mannkind become a profitable BP and not just a “going concern” and anxious for the next success to add fuel to this transport to help convert it from a paddlewheeler working upstream to a rocket ship. |
|
|
|
Post by sayhey24 on Jan 27, 2023 14:38:03 GMT -5
Will MNKD find a partner for Clofazimine? I don't think so. The ONLY player is Novartis and I don't see them wanting to get back into this market. I see Mike going SOLO. It's not like Novartis is currently marketing this drug. I also think Mike knows the value of owning your own drug. Q: Will there be any ownership/patent issues with Novartis?? This drug was resurrected by Hoffman so I'm wondering if there will be a legal battle of the rights? I would be shocked if Mike did not do due diligence one this one prior to starting this journey. If I understand correctly the target market would be pulmonologists. Is that correct? Isn't that the same market UTHR is selling Tyvaso DPI into? If so, wouldn't the obvious partner be UTHR if Mike can negotiate the proper royalty deal for them to sell the product? Whats clear is UTHR sales seems to be doing a pretty great job with Tyvaso DPI. |
|
|
|
Post by hellodolly on Jan 27, 2023 14:59:08 GMT -5
Will MNKD find a partner for Clofazimine? I don't think so. The ONLY player is Novartis and I don't see them wanting to get back into this market. I see Mike going SOLO. It's not like Novartis is currently marketing this drug. I also think Mike knows the value of owning your own drug. Q: Will there be any ownership/patent issues with Novartis?? This drug was resurrected by Hoffman so I'm wondering if there will be a legal battle of the rights? I would be shocked if Mike did not do due diligence one this one prior to starting this journey. If I understand correctly the target market would be pulmonologists. Is that correct? Isn't that the same market UTHR is selling Tyvaso DPI into? If so, wouldn't the obvious partner be UTHR if Mike can negotiate the proper royalty deal for them to sell the product? Whats clear is UTHR sales seems to be doing a pretty great job with Tyvaso DPI. UTHR is such an "obvious organizational fit" when you consider the line of products MNKD is researching, developing and manufacturing. Not to mention MNKD has the device(s), the technology, the IP and there is UTHR (on their end) committed to building another manufacturing plant (albeit contractually obligated). What makes it an obvious organizational fit? Well, besides what I briefly skimmed through in my response, UTHR seems dedicated to near exclusive focus on addressing various indications that are related to lung function. As I noted in another thread, with the exception of V-Go, the Technsophere platform fits into that basket. |
|
|
|
Post by sayhey24 on Jan 28, 2023 8:26:40 GMT -5
I would be shocked if Mike did not do due diligence one this one prior to starting this journey. If I understand correctly the target market would be pulmonologists. Is that correct? Isn't that the same market UTHR is selling Tyvaso DPI into? If so, wouldn't the obvious partner be UTHR if Mike can negotiate the proper royalty deal for them to sell the product? Whats clear is UTHR sales seems to be doing a pretty great job with Tyvaso DPI. UTHR is such an "obvious organizational fit" when you consider the line of products MNKD is researching, developing and manufacturing. Not to mention MNKD has the device(s), the technology, the IP and there is UTHR (on their end) committed to building another manufacturing plant (albeit contractually obligated). What makes it an obvious organizational fit? Well, besides what I briefly skimmed through in my response, UTHR seems dedicated to near exclusive focus on addressing various indications that are related to lung function. As I noted in another thread, with the exception of V-Go, the Technsophere platform fits into that basket. For me what makes this an obvious fit is 1. The 2 companies already have a great working relationship 2. UTHR wants to increase revenue 3. UTHR is already calling on the correct doctors 4. UTHR has a sales force that knows how to sell 5. MNKD has no sales force calling on these doctors and the existing one is still learning how to sell product. 6. Building and feeding a new sales force is expensive and takes time The big question is what the negotiated royalty would be. Clearly, if MNKD owns it and takes it through P3, its not a 10% deal like Tyvaso DPI. |
|
|
|
Post by prcgorman2 on Jan 28, 2023 11:03:11 GMT -5
UTHR is such an "obvious organizational fit" when you consider the line of products MNKD is researching, developing and manufacturing. Not to mention MNKD has the device(s), the technology, the IP and there is UTHR (on their end) committed to building another manufacturing plant (albeit contractually obligated). What makes it an obvious organizational fit? Well, besides what I briefly skimmed through in my response, UTHR seems dedicated to near exclusive focus on addressing various indications that are related to lung function. As I noted in another thread, with the exception of V-Go, the Technsophere platform fits into that basket. For me what makes this an obvious fit is 1. The 2 companies already have a great working relationship 2. UTHR wants to increase revenue 3. UTHR is already calling on the correct doctors 4. UTHR has a sales force that knows how to sell 5. MNKD has no sales force calling on these doctors and the existing one is still learning how to sell product. 6. Building and feeding a new sales force is expensive and takes time The big question is what the negotiated royalty would be. Clearly, if MNKD owns it and takes it through P3, its not a 10% deal like Tyvaso DPI. Love your post. I’ve assumed Mannkind’s treprostinil Phase 1 trial was a fishing expedition that landed a whopping good deal. It was great for UTHR (obviously) and it was great for Mannkind, but probably would have been even better had Mannkind not been desparate for a partner. The desparation is gone, so your point is a good one. And I can easily imagine Dr. Rothblatt might have told Dr. Castagna, “If you get promising results with Phase 1 trial of clofazimine, we’ll be interested to look at what you’ve got”. I’m positive that’s an oversimplification, but perhaps the gist. If nothing else, UTHR is an obvious candidate for a partner. |
|
|
|
Post by hellodolly on Jan 28, 2023 14:02:22 GMT -5
For me what makes this an obvious fit is 1. The 2 companies already have a great working relationship 2. UTHR wants to increase revenue 3. UTHR is already calling on the correct doctors 4. UTHR has a sales force that knows how to sell 5. MNKD has no sales force calling on these doctors and the existing one is still learning how to sell product. 6. Building and feeding a new sales force is expensive and takes time The big question is what the negotiated royalty would be. Clearly, if MNKD owns it and takes it through P3, its not a 10% deal like Tyvaso DPI. Love your post. I’ve assumed Mannkind’s treprostinil Phase 1 trial was a fishing expedition that landed a whopping good deal. It was great for UTHR (obviously) and it was great for Mannkind, but probably would have been even better had Mannkind not been desparate for a partner. The desparation is gone, so your point is a good one. And I can easily imagine Dr. Rothblatt might have told Dr. Castagna, “If you get promising results with Phase 1 trial of clofazimine, we’ll be interested to look at what you’ve got”. I’m positive that’s an oversimplification, but perhaps the gist. If nothing else, UTHR is an obvious candidate for a partner. Ditto! |
|
|
|
Post by phdedieu12 on Jan 28, 2023 22:47:46 GMT -5
I get the point of view but don't we ultimately want to go alone rather than continually splitting with partners? Yes, we didn't have much of a choice when we were broke, but isn't the point of raising capital and becoming positive to no longer need partners?
|
|
|
|
Post by caesar on Jan 28, 2023 23:02:11 GMT -5
I get the point of view but don't we ultimately want to go alone rather than continually splitting with partners? Yes, we didn't have much of a choice when we were broke, but isn't the point of raising capital and becoming positive to no longer need partners? Being alone is no "fun"! Partners can become meaningful in many ways - United has a sales team in place that will ramp up sales ASAP. Just saying |
|
