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Post by awesomo on Nov 21, 2019 17:59:19 GMT -5
No, it will not fully transition all Tyvaso sales instantly over after FDA approval. I doubt we get even close to $10M per quarter until the launch is ramped up and the demand is seen.
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Post by mango on Nov 21, 2019 17:59:27 GMT -5
Is there a source for this information? I've never heard of needing to redo a trial because of a different API source and google isn't helping me. It's also strange to me that they are doing the healthy trial after the tyvaso sitch to TreT trial -- it seems like the healthy trial to establish pharmacokinetics should have been first. You can find the information on the board. I think it was Matt that posted the definitive reply. The reason why is that not all APIs are created equal so source matters. So, for any drug on the market today that is FDA approved, if a company’s source of the API is changed—new clinical trials are required before it can be used? |
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Post by cretin11 on Nov 21, 2019 18:02:22 GMT -5
No, it will not fully transition all Tyvaso sales instantly over after FDA approval. I doubt we get even close to $10M per quarter until the launch is ramped up and the demand is seen. I don't like that, though it is a good point. But do you think 24 months is a reasonable estimate (guess?) on when FDA approval could happen? |
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Post by ktim on Nov 21, 2019 18:11:37 GMT -5
So are we collectively comfortable with a prediction of around $10M royalties per quarter, to hopefully hit our bottom line within a time frame of maybe the next 24 months? Just putting it out there for folks to weigh in (on either side of that model). To prcgorman's initial point, it is relevant to predicting when/if we'll get to CFBE and beyond. Seems a plausible scenario. Would be interesting if there was some case history of a similar situation with a superior delivery method being marketed by a company to replace their existing product to gauge how quickly it might happen. Though I doubt there is something exactly analogous. I suppose one could argue the introduction of Fiasp or Tresiba are somewhat similar. Is there a possibility UTHR will/can pull Tyvaso from the market at some point ? ? |
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Post by agedhippie on Nov 21, 2019 18:17:33 GMT -5
You can find the information on the board. I think it was Matt that posted the definitive reply. The reason why is that not all APIs are created equal so source matters. So, for any drug on the market today that is FDA approved, if a company’s source of the API is changed—new clinical trials are required before it can be used? You would need Matt to answer that question. I *think* there is a single equivalence trial, which is what you are seeing here, when you swap API. There was no other trial work done by Mannkind so it's simpler and cleaner just to redo the trial in this case rather than doing that equivalence trial - especially since they will both be the same amount of work. |
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Post by boca1girl on Nov 21, 2019 18:19:42 GMT -5
So are we collectively comfortable with a prediction of around $10M royalties per quarter, to hopefully hit our bottom line within a time frame of maybe the next 24 months? Just putting it out there for folks to weigh in (on either side of that model). To prcgorman's initial point, it is relevant to predicting when/if we'll get to CFBE and beyond. Seems a plausible scenario. Would be interesting if there was some case history of a similar situation with a superior delivery method being marketed by a company to replace their existing product to gauge how quickly it might happen. Though I doubt there is something exactly analogous. I suppose one could argue the introduction of Fiasp or Tresiba are somewhat similar. Is there a possibility UTHR will/can pull Tyvaso from the market at some point ? ? I would expect them to transition all of the current patients to TreT over time (12 months?) and discontinue production of the current product. Unless there is some reason why TreT would not work for current patients, UT will probably announce a phase out plan of the current product when they introduce the new. |
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Post by rfogel on Nov 21, 2019 18:23:44 GMT -5
You can find the information on the board. I think it was Matt that posted the definitive reply. The reason why is that not all APIs are created equal so source matters. So, for any drug on the market today that is FDA approved, if a company’s source of the API is changed—new clinical trials are required before it can be used? If I'm reading this correctly -- www.fda.gov/media/71321/download -- an in vivo demonstration of bioequivalence is required if there is some reason to believe that there was a difference between what was used in the original study and what is now going to be used in the product. They give as examples: "Lack of adequate controls· Evidence of adulteration· Evidence of falsification of data in the application or identified in the preapproval inspection." ." |
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Post by agedhippie on Nov 21, 2019 18:23:50 GMT -5
So are we collectively comfortable with a prediction of around $10M royalties per quarter, to hopefully hit our bottom line within a time frame of maybe the next 24 months? Just putting it out there for folks to weigh in (on either side of that model). To prcgorman's initial point, it is relevant to predicting when/if we'll get to CFBE and beyond. Seems a plausible scenario. Would be interesting if there was some case history of a similar situation with a superior delivery method being marketed by a company to replace their existing product to gauge how quickly it might happen. Though I doubt there is something exactly analogous. I suppose one could argue the introduction of Fiasp or Tresiba are somewhat similar. Is there a possibility UTHR will/can pull Tyvaso from the market at some point ? ? Fiasp wouldn't be a bad comparison. Novo Nordisk sell it for the same price as Novolog and tell everyone they should swap. At some point they may withdraw Tyvaso, but not until it's market share disappears. More likely they simply stop promoting it and let it trail off on it's own. There may be a percentage of patients who cannot use TreT or have problems with the cough, but that seems likely to be small given that Tyvaso is also inhaled. |
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Post by mnholdem on Nov 21, 2019 19:26:22 GMT -5
Again, to use the Fiasp example, adoption could go much faster. Same drug with a more patient-friendly inhaler.
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Post by brotherm1 on Nov 21, 2019 21:01:25 GMT -5
No, it will not fully transition all Tyvaso sales instantly over after FDA approval. I doubt we get even close to $10M per quarter until the launch is ramped up and the demand is seen. And could the billion plus dollar ralinepag render trepostinil obsolete ? clinicaltrials.gov/ct2/results?term=ralinepag&Search=Search |
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Post by Deleted on Nov 21, 2019 21:49:51 GMT -5
I doubt Ralinepag will make TreT obsolete. Cost will be factor and most doctors will provide the cheapest drug to their patient. They will
sacrifice performance for cost.
Also what happens if Ralinepag gets DELAYED or CRL'd by the FDA? Then UTHR could be in trouble without a Plan B.
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Post by agedhippie on Nov 21, 2019 23:11:36 GMT -5
I doubt Ralinepag will make TreT obsolete. Cost will be factor and most doctors will provide the cheapest drug to their patient. They will sacrifice performance for cost. ... Doctors won't, but insurers will in a heart beat! |
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Post by figglebird on Nov 25, 2019 16:46:48 GMT -5
I think the most compelling near term issue here is not if or when label expansion takes place(in theory one of two pivotal factors towards achieving a sustainable rise in valuation/along a pediatric approval) - it is the unknown implications of lqda's NDA path for an equivalent biosimilar to tyvasso - and a lead over uthrs in the arms race - if lqda gets approval what will uthr do?
Well, if we look to the past, there have been several instances in which their moat has been challanges in this regard spurring then into action in the 2 following ways...
1. Law suits - over patent infringement and brand exclusivity
2. Acquisitions- such as w trrveyant which was brought to mkt by steady med whom they bought
So far it is impossible to know how this plays out, HOWEVER, the fact lqda has now suspended a pre NDA mtg w FDA due to fdas straight fwd response in terms of expectations, we are certainly approaching this potential complicating factor, sooner than later.
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Post by rfogel on Nov 25, 2019 17:13:50 GMT -5
I think the most compelling near term issue here is not if or when label expansion takes place(in theory one of two pivotal factors towards achieving a sustainable rise in valuation/along a pediatric approval) - it is the unknown implications of lqda's NDA path for an equivalent biosimilar to tyvasso - and a lead over uthrs in the arms race - if lqda gets approval what will uthr do? Well, if we look to the past, there have been several instances in which their moat has been challanges in this regard spurring then into action in the 2 following ways... 1. Law suits - over patent infringement and brand exclusivity 2. Acquisitions- such as w trrveyant which was brought to mkt by steady med whom they bought So far it is impossible to know how this plays out, HOWEVER, the fact lqda has now suspended a pre NDA mtg w FDA due to fdas straight fwd response in terms of expectations, we are certainly approaching this potential complicating factor, sooner than later. You say that Liquidia "has now suspended a pre NDA mtg w FDA," but in their conference call last week they said "we are engaged in pre-NDA meetings with FDA in preparation for the NDA submission targeted for the first quarter of 2020." Did I miss a news bulletin somewhere? |
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Post by figglebird on Nov 25, 2019 17:52:23 GMT -5
Yes... from what I read today the MTg was deemed unnecessary based on FDA communication
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