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Post by hopingandwilling on Apr 30, 2020 19:51:27 GMT -5
Mango,
They can’t file the drug under a 505 application if the drug doesn’t show bioavailability between the two drugs. United needs for Tre-t and Tyvaso to match..and certainly Mannkind needs for this happening..and soon. IMO
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Post by radgray68 on May 1, 2020 12:20:11 GMT -5
Would we start to get paid royalties for the patients who choose to continue on the Tre-T? I can't see a reason why we wouldn't. Service ordered, service provided. I'd love to see another source of revenue appear on our balance sheet sooner than analysts predict. FDA doesn't have some left field rules about that do they? It's only 45 patients in the trial. Both the greedy capitalist AND the longtime suffering Mannkind investor in me say "I'll take it. Where's my check?" 😂 |
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Post by rfogel on May 1, 2020 15:05:22 GMT -5
Mango, They can’t file the drug under a 505 application if the drug doesn’t show bioavailability between the two drugs. United needs for Tre-t and Tyvaso to match..and certainly Mannkind needs for this happening..and soon. IMO Did Mannkind's phase 1 fail to reveal the bioavailability and/or pharmacokinetics? I'm having trouble seeing what more the FDA wants as regards "bioequivalence." |
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Post by casualinvestor on May 1, 2020 19:30:22 GMT -5
I thought that the Mankind study was with healthy volunteers and Breeze has people with PAH.
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Post by brotherm1 on May 3, 2020 9:04:24 GMT -5
So with the study delay, I’m wondering if this now means we will not see the anticipated $12.5M milestone this month.
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Post by rfogel on May 3, 2020 13:36:09 GMT -5
I thought that the Mankind study was with healthy volunteers and Breeze has people with PAH. As I currently understand it, the original "breeze" study is with PAH victims. but then it sounds like the FDA required an additional study with helthy volunteers to establish "bioequivalence." However, I don't see what more beyond Mannkind's original phase 1 is needed to do that. If anything, you'd think that the responses of the PAH patients would tell them more about the true functional bioequivalence. |
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Post by matt on May 4, 2020 7:53:48 GMT -5
I thought that the Mankind study was with healthy volunteers and Breeze has people with PAH. As I currently understand it, the original "breeze" study is with PAH victims. but then it sounds like the FDA required an additional study with helthy volunteers to establish "bioequivalence." However, I don't see what more beyond Mannkind's original phase 1 is needed to do that. If anything, you'd think that the responses of the PAH patients would tell them more about the true functional bioequivalence. In one case you are dosing healthy subjects without impaired lung function, and in the other you are dosing PAH patients with a high degree of functional impairment. Would it be surprising to discover that equivalence can be achieved in the healthy group but not in those with impaired function? FDA generally wants to see the kinetics on healthy volunteers because if something goes wrong in the trial it is much easier to reverse the side effects in healthy subjects. While adverse events are rarely seen in a healthy Phase I cohort, it can and does happen because animal data is not always predictive of what is going to happen in humans and in rare cases those effects have been severe and life-threatening. Once the basic data has been established in healthy subjects, the company needs to show equivalence in patients with the disease. That is the ultimate test of whether a new medication will work for the intended population, and FDA will not let the sponsor simply assume that because it worked in healthy subjects that it will be the same in patients with the disease. The burden to prove safety and efficacy is on the sponsor, not the regulatory agency. |
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Post by casualinvestor on May 4, 2020 10:02:15 GMT -5
I posted this in Nov. Re-posting for reference:
Breeze is not finished yet, so hopefully UTHR with run that and the new one in parallel. Dates from BREEZE:
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020
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Post by rfogel on May 4, 2020 13:00:04 GMT -5
As I currently understand it, the original "breeze" study is with PAH victims. but then it sounds like the FDA required an additional study with helthy volunteers to establish "bioequivalence." However, I don't see what more beyond Mannkind's original phase 1 is needed to do that. If anything, you'd think that the responses of the PAH patients would tell them more about the true functional bioequivalence. In one case you are dosing healthy subjects without impaired lung function, and in the other you are dosing PAH patients with a high degree of functional impairment. Would it be surprising to discover that equivalence can be achieved in the healthy group but not in those with impaired function? FDA generally wants to see the kinetics on healthy volunteers because if something goes wrong in the trial it is much easier to reverse the side effects in healthy subjects. While adverse events are rarely seen in a healthy Phase I cohort, it can and does happen because animal data is not always predictive of what is going to happen in humans and in rare cases those effects have been severe and life-threatening. Once the basic data has been established in healthy subjects, the company needs to show equivalence in patients with the disease. That is the ultimate test of whether a new medication will work for the intended population, and FDA will not let the sponsor simply assume that because it worked in healthy subjects that it will be the same in patients with the disease. The burden to prove safety and efficacy is on the sponsor, not the regulatory agency. That's all well and good but haven't they already done a third of the original study with PAH patients? Seems a bit late to be worrying about something going "wrong" now -- that is unless something disconcerting showed up in those first patients. Besides, didn't Mannkind's original study establish safety? |
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Post by mango on May 4, 2020 13:26:50 GMT -5
In one case you are dosing healthy subjects without impaired lung function, and in the other you are dosing PAH patients with a high degree of functional impairment. Would it be surprising to discover that equivalence can be achieved in the healthy group but not in those with impaired function? FDA generally wants to see the kinetics on healthy volunteers because if something goes wrong in the trial it is much easier to reverse the side effects in healthy subjects. While adverse events are rarely seen in a healthy Phase I cohort, it can and does happen because animal data is not always predictive of what is going to happen in humans and in rare cases those effects have been severe and life-threatening. Once the basic data has been established in healthy subjects, the company needs to show equivalence in patients with the disease. That is the ultimate test of whether a new medication will work for the intended population, and FDA will not let the sponsor simply assume that because it worked in healthy subjects that it will be the same in patients with the disease. The burden to prove safety and efficacy is on the sponsor, not the regulatory agency. That's all well and good but haven't they already done a third of the original study with PAH patients? Seems a bit late to be worrying about something going "wrong" now -- that is unless something disconcerting showed up in those first patients. Besides, didn't Mannkind's original study establish safety? Email MannKind IR about it and post their response here. |
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