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Post by louaboardalia on Mar 21, 2020 14:22:09 GMT -5
Here we sit in shock as one state after another issues "stay-at-home" orders, with no effective leadership to be found at the top. Daily we hear more about the need for respiratory relief of those experiencing the effects of COVID-19, as our medical professionals become more alarmed by the scarcity of Albuterol Inhalers.
Here in Washington State, Flolan is now being used to treat PAH issues, which is a drug described as: "Flolan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%)."
Remind you of anything? Me too. It’s called Trep-T and I ask: What are UTHR and MNKD doing to advance Trep-T’s approval?
The way I see it, UTHR/MNKD have a clear and rare opportunity to present the existing data to the FDA with a request for a "compassionate use" determination or other form of approval to produce and distribute Trep-T for the treatment of respiratory complications from COVID-19. They already know and can show Trep-T’s efficacy and it’s time to push that information into the face of the FDA, medical professionals and public.
Instead, we only hear of a new MNKD "collaboration with Immix Biopharma, Inc. to prepare a dry powder formulation of a compound with the potential to treat acute respiratory distress syndrome, a complication of COVID-19." Finding very little online about Immix, it sounds like a desperate public relations attempt by MNKD, rather than something of significance to MNKD shareholders. I thought we were already in collaboration with UTHR to essentially do the same.
To MNKD and UTHR management: Trep-T is clearly needed so I ask that you seize upon this opportunity to get it approved!!
Thoughts?
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Post by matt on Mar 21, 2020 15:03:08 GMT -5
The underlying drug is already manufactured by UTHR and it is approved for sale. There is no need for any approval on the UTHR side if physicians want to try it for treating any disease; that is what off-label prescribing is all about. Any licensed physician can used any approved drug for treating any condition where, in the professional judgment of the physician, the treatment is warranted. Naturally when a physician prescribes a drug off-label, they are solely responsible for the consequences if the patient suffers adverse events but in life threatening situations few people second guess physicians.
The new formulation is not MNKD's drug, just MNKD's delivery system. Does UTHR feel a pressing need to push the new formulation through FDA at this time?
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Post by letitride on Mar 21, 2020 15:26:30 GMT -5
The underlying drug is already manufactured by UTHR and it is approved for sale. There is no need for any approval on the UTHR side if physicians want to try it for treating any disease; that is what off-label prescribing is all about. Any licensed physician can used any approved drug for treating any condition where, in the professional judgment of the physician, the treatment is warranted. Naturally when a physician prescribes a drug off-label, they are solely responsible for the consequences if the patient suffers adverse events but in life threatening situations few people second guess physicians. The new formulation is not MNKD's drug, just MNKD's delivery system. Does UTHR feel a pressing need to push the new formulation through FDA at this time? I could see UTHR seizing the moment if they believe there is actual need to. Thats what UTHR was built on. |
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Post by ktim on Mar 21, 2020 19:13:44 GMT -5
Where is there any indication Trep would help with COVID-19 ARDS? Just because something goes in the lungs doesn't mean it solves all lung issues. Am I missing something?
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Post by akemp3000 on Mar 22, 2020 5:29:36 GMT -5
Not sure anyone has suggested Trep-T would help with COVID-19 or solve lung issues but it sure sounds like it would help with symptoms of lung issues and improve quality of life for those with complications. Let's hope UTHR pushes to fast track and promote it since Martine has already suggested its going to replace current therapy.
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Post by stevil on Mar 22, 2020 9:06:27 GMT -5
It is highly unlikely that Trep-T would do anything of benefit for coronavirus patients.
Trep-T is a vasodilator, which means it improves blood flow to the lungs. The issue with coronavirus is not that the lungs are starved for blood. It's a pneumonia which causes consolidation of fluid in the parenchyma of the lung. Essentially, this causes dead space in the lung that blocks air from participating in blood/gas exchange.
Hopefully more simply stated, if the lung is like a balloon, if you fill part of the balloon with water, that part of the balloon will no longer be able to be filled with air as there is already something taking its place. The lung is already being properly supplied with blood- that's not the issue. The issue is that the blood that is reaching the lungs cannot participate in blood/gas exchange because the surface area of the lungs is reduced.
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Post by peppy on Mar 22, 2020 9:35:01 GMT -5
It is highly unlikely that Trep-T would do anything of benefit for coronavirus patients. Trep-T is a vasodilator, which means it improves blood flow to the lungs. The issue with coronavirus is not that the lungs are starved for blood. It's a pneumonia which causes consolidation of fluid in the parenchyma of the lung. Essentially, this causes dead space in the lung that blocks air from participating in blood/gas exchange. Hopefully more simply stated, if the lung is like a balloon, if you fill part of the balloon with water, that part of the balloon will no longer be able to be filled with air as there is already something taking its place. The lung is already being properly supplied with blood- that's not the issue. The issue is that the blood that is reaching the lungs cannot participate in blood/gas exchange because the surface area of the lungs is reduced. , where are you? Have you walked into a room yet where the patient is wet and short of breath, labored? What are you doing for personal protection? |
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Post by stevil on Mar 22, 2020 12:20:57 GMT -5
It is highly unlikely that Trep-T would do anything of benefit for coronavirus patients. Trep-T is a vasodilator, which means it improves blood flow to the lungs. The issue with coronavirus is not that the lungs are starved for blood. It's a pneumonia which causes consolidation of fluid in the parenchyma of the lung. Essentially, this causes dead space in the lung that blocks air from participating in blood/gas exchange. Hopefully more simply stated, if the lung is like a balloon, if you fill part of the balloon with water, that part of the balloon will no longer be able to be filled with air as there is already something taking its place. The lung is already being properly supplied with blood- that's not the issue. The issue is that the blood that is reaching the lungs cannot participate in blood/gas exchange because the surface area of the lungs is reduced. , where are you? Have you walked into a room yet where the patient is wet and short of breath, labored? What are you doing for personal protection? Fortunately for me, I don't have to see these patients since PPE is so limited. It would be a waste for me to gown, glove, and mask up just to have my attending come in behind me and have to do the same, regardless. |
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Post by babaoriley on Mar 22, 2020 12:33:45 GMT -5
Everyone on this entire board should look up the Dunning Kruger Effect ("DKE") - it applies to most all genuine posters on all stock message boards (me too!). The disingenuous posters are just disgusting, but do not exhibit DKE, although they, too, may suffer from it.
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Post by ktim on Mar 22, 2020 12:34:55 GMT -5
Not sure anyone has suggested Trep-T would help with COVID-19 or solve lung issues but it sure sounds like it would help with symptoms of lung issues and improve quality of life for those with complications. Let's hope UTHR pushes to fast track and promote it since Martine has already suggested its going to replace current therapy. Serious question... what makes you think it would help with symptoms from a viral infection. I get being hopeful, but I don't get using COVID as yet another opportunity to hype one's portfolio. This is serious. Real people are affected. We don't have to make money off of everything I'm sure some will complain as if I'm the one preventing MNKD from providing a cure for a deadly disease. There isn't a cure... other than the fact that this problem will be stopped in its tracks as soon as we all take the minor inconvenience of staying the f home. Sorry, right now I have loved ones in harms way. Stay healthy, Stay home! |
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Post by ktim on Mar 22, 2020 12:41:42 GMT -5
stevil , where are you? Have you walked into a room yet where the patient is wet and short of breath, labored? What are you doing for personal protection? Fortunately for me, I don't have to see these patients since PPE is so limited. It would be a waste for me to gown, glove, and mask up just to have my attending come in behind me and have to do the same, regardless. Stay well. Thanks times ten. When you're helping someone, that's my mother, my brother, it's the people we love. |
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