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Post by biotec on Oct 4, 2021 7:57:30 GMT -5
Just guessing below $3 and over $6 How many people are hedged with puts against a large share position? I'm thinking below $2 and over $10 |
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Post by hellodolly on Oct 5, 2021 12:55:50 GMT -5
I wanted to research the information on the current delivery system for TYVASO. I found the "Instruction Manual" regarding the nebulizer. Besides the fact that the nebulizer is bulky and awkward to carry and conceal, you'll need to find electricity if you're out and the battery dies. Oh, the manual...its 91 pages long.
I looked at the Mannkind site to find the manual for the cricket that will most surely support the delivery of the new inhaled version of Tyvaso. Besides what we already know, it's small, concealable and easy to carry in one's purse or pocket, it doesn't use electricity and the manual is only 3 pages long.
I think we can say this is should be appealing to users, prescribing doctors and to the overall margins for UTHR.
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Post by neil36 on Oct 5, 2021 13:24:45 GMT -5
I wanted to research the information on the current delivery system for TYVASO. I found the "Instruction Manual" regarding the nebulizer. Besides the fact that the nebulizer is bulky and awkward to carry and conceal, you'll need to find electricity if you're out and the battery dies. Oh, the manual...its 91 pages long. I looked at the Mannkind site to find the manual for the cricket that will most surely support the delivery of the new inhaled version of Tyvaso. Besides what we already know, it's small, concealable and easy to carry in one's purse or pocket, it doesn't use electricity and the manual is only 3 pages long. I think we can say this is should be appealing to users, prescribing doctors and to the overall margins for UTHR. This YouTube video, on the day in the life of a Tyvaso user, is quite eye-opening. I find it hard to imagine that many patients would opt to stay with this contraption, once offered a DPI alternative youtu.be/n_wGAkEjwYE |
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Post by hellodolly on Oct 5, 2021 14:26:19 GMT -5
I wanted to research the information on the current delivery system for TYVASO. I found the "Instruction Manual" regarding the nebulizer. Besides the fact that the nebulizer is bulky and awkward to carry and conceal, you'll need to find electricity if you're out and the battery dies. Oh, the manual...its 91 pages long. I looked at the Mannkind site to find the manual for the cricket that will most surely support the delivery of the new inhaled version of Tyvaso. Besides what we already know, it's small, concealable and easy to carry in one's purse or pocket, it doesn't use electricity and the manual is only 3 pages long. I think we can say this is should be appealing to users, prescribing doctors and to the overall margins for UTHR. This YouTube video, on the day in the life of a Tyvaso user, is quite eye-opening. I find it hard to imagine that many patients would opt to stay with this contraption, once offered a DPI alternative youtu.be/n_wGAkEjwYEThanks. My mind didn't go there today to even check. Eye-opening and I agree on the convenience factor. I have to wonder what the UTHR plan is for promoting the new device? I'm assuming it's going to include literature for the doctors that includes the summary of the trial and the high percentage of users that opted to stay on the device after the trial concluded. |
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Post by sellhighdrinklow on Oct 5, 2021 14:41:32 GMT -5
If I recall correctly, there were 52+/- participating in the study, a few dropped out for unknown reasons and the remaining study participants, at end of study, had option to stay on current system or officially go
w DPI. Are those study participants currently allowed to use DPI or do they need to wait until FDA gives full approval?
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Post by sportsrancho on Oct 5, 2021 17:10:33 GMT -5
I wanted to research the information on the current delivery system for TYVASO. I found the "Instruction Manual" regarding the nebulizer. Besides the fact that the nebulizer is bulky and awkward to carry and conceal, you'll need to find electricity if you're out and the battery dies. Oh, the manual...its 91 pages long. I looked at the Mannkind site to find the manual for the cricket that will most surely support the delivery of the new inhaled version of Tyvaso. Besides what we already know, it's small, concealable and easy to carry in one's purse or pocket, it doesn't use electricity and the manual is only 3 pages long. I think we can say this is should be appealing to users, prescribing doctors and to the overall margins for UTHR. This YouTube video, on the day in the life of a Tyvaso user, is quite eye-opening. I find it hard to imagine that many patients would opt to stay with this contraption, once offered a DPI alternative youtu.be/n_wGAkEjwYESo Neil… You can exercise right after you take it but then the ability to do that decreases three hours later? And that’s why they have you taking it throughout the day…. wow, it looks like a big pain! |
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Post by prcgorman2 on Oct 5, 2021 20:28:56 GMT -5
If I recall correctly, there were 52+/- participating in the study, a few dropped out for unknown reasons and the remaining study participants, at end of study, had option to stay on current system or officially go w DPI. Are those study participants currently allowed to use DPI or do they need to wait until FDA gives full approval? I do not know the answer to your question but the way the study results read regarding their opt-in on continuing with DPI, I kind of assumed they were grandfathered in under trial agreement until FDA approval (or not). Good question though. |
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Post by hellodolly on Oct 6, 2021 7:17:09 GMT -5
Issued by MNKD in January 2021:
Optional Extension Phase.
"Subjects in BREEZE were given the opportunity to continue in an OEP. All subjects who completed the treatment phase (49/51) elected to continue in the OEP."
If the OEP is designed to study the long term use of the TYVASO, DPI, it would seem logical that they are staying with the Cricket and the dry powder.
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Post by nxc2 on Oct 6, 2021 7:32:29 GMT -5
I wanted to research the information on the current delivery system for TYVASO. I found the "Instruction Manual" regarding the nebulizer. Besides the fact that the nebulizer is bulky and awkward to carry and conceal, you'll need to find electricity if you're out and the battery dies. Oh, the manual...its 91 pages long. I looked at the Mannkind site to find the manual for the cricket that will most surely support the delivery of the new inhaled version of Tyvaso. Besides what we already know, it's small, concealable and easy to carry in one's purse or pocket, it doesn't use electricity and the manual is only 3 pages long. I think we can say this is should be appealing to users, prescribing doctors and to the overall margins for UTHR. This YouTube video, on the day in the life of a Tyvaso user, is quite eye-opening. I find it hard to imagine that many patients would opt to stay with this contraption, once offered a DPI alternative youtu.be/n_wGAkEjwYEWow - eye-opener for sure. I did not watch entire video but imagine the cleaning of the device that is needed! Going to be great for the patients to just take a puff and discard device after 30 days. Very exciting! |
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Post by kite on Oct 6, 2021 10:32:55 GMT -5
I thought that was Martha Stewart in the video...
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Post by ktim on Oct 6, 2021 12:53:25 GMT -5
So, I believe the FDA decision is anticipated by the end of the month. What are expectations for the MNKD share price, in the cases of both approval and non-approval? I wonder if an options straddle would be a good strategy about now. I see the November 4.50 call and put each last traded at 0.55 and 0.65, respectively. I've often wondered whether options straddles going into FDA decisions could generally be profitable. As with MNKD now, often the options become quite pricey. Wish I knew an easy way of back testing a straddle strategy looking historically at anticipated FDA decision dates. Do you have experience with doing straddles against FDA decisions? |
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Post by ktim on Oct 6, 2021 13:03:30 GMT -5
So, I believe the FDA decision is anticipated by the end of the month. What are expectations for the MNKD share price, in the cases of both approval and non-approval? I wonder if an options straddle would be a good strategy about now. I see the November 4.50 call and put each last traded at 0.55 and 0.65, respectively. Just guessing below $3 and over $6 How many people are hedged with puts against a large share position? I was short puts for most of this year and have now let those expire so I've moved in that direction  Seems like very expensive insurance to actually buy puts. |
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Post by sportsrancho on Oct 6, 2021 14:02:52 GMT -5
I don’t have any puts but my five dollar calls are obviously in the money and my six dollar calls have moved up $.20😎🧨
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Post by goyocafe on Oct 8, 2021 4:38:03 GMT -5
So what’s the FDA going to do? Are they going to add a black box warning to the Tyvaso-DPI label for severe bronchspasm, or are they going to remove the same from the Afrezza label? It’s hard to contemplate it existing for one and not the other. But then again, it’s the FDA.
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Post by hellodolly on Oct 8, 2021 6:26:12 GMT -5
So what’s the FDA going to do? Are they going to add a black box warning to the Tyvaso-DPI label for severe bronchspasm, or are they going to remove the same from the Afrezza label? It’s hard to contemplate it existing for one and not the other. But then again, it’s the FDA. During the UTHR sponsored trials, did they discover that as any of the SAEs in the trial? |
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