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Post by hellodolly on Oct 30, 2023 11:34:00 GMT -5
Thanks for your input, HelloDolly. Yeah, I was afraid it might be second-half of 2025. So, if MNKD did decide to go on to follow-up with a DPI version, that would probably be another couple years after that (late 2027) before it would be sold. You are welcome friend. I'm not sure they need the expense for a DPI version, trials, formulations, etc. Nebulizer is just fine in 2025. Here is my main argument as to why: The course of treatment is very short lived, 28 days treatment, 60 day holiday and then 28 days of treatment. Of course the trial says another 60 day drug holiday but, if you're clear after two courses and in 60 days you meet with your doctor to get your labs to verify the bacteria is eliminated, beginning to end process takes a very short six months. Need to always think about the possibility that they may want to do a phase IV follow on trial if they think in the regular course of administration during the upcoming PHII/III trial...say, only +60% of the patients cleared the disease, they'll (MNKD and FDA) likely want to see if a third course can help the remaining 40% of the patients while also measuring toxicity levels. So, approval to move ahead with the BLA and a conditional request for a PHIV follow on, depending on PHII/III outcomes. So, in summary, I don't see a need for the expense since the nebulizer is already a FDA approved medical device AND the treatment is very short.
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Post by Clement on Oct 30, 2023 12:07:49 GMT -5
Thanks for your input, HelloDolly. Yeah, I was afraid it might be second-half of 2025. So, if MNKD did decide to go on to follow-up with a DPI version, that would probably be another couple years after that (late 2027) before it would be sold. I respect your comment and it makes good sense. However, look at what happened with the trial for Tyvaso in PH-ILD. The trial was performed with Tyvaso-nebulizer. Then T-DPI was allowed later without a specific trial for DPI. And the TETON trial is being done with Tyvaso-nebulizer and UTHR expects to sell T-DPI there without a separate trial for DPI. Maybe MNKD can copy that pattern?
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Post by hellodolly on Oct 30, 2023 12:13:22 GMT -5
Thanks for your input, HelloDolly. Yeah, I was afraid it might be second-half of 2025. So, if MNKD did decide to go on to follow-up with a DPI version, that would probably be another couple years after that (late 2027) before it would be sold. I respect your comment and it makes good sense. However, look at what happened with the trial for Tyvaso in PH-ILD. The trial was performed with Tyvaso-nebulizer. Then T-DPI was allowed later without a specific trial for DPI. And the TETON trial is being done with Tyvaso-nebulizer and UTHR expects to sell T-DPI there without a separate trial for DPI. Maybe MNKD can copy that pattern? I like that thought process. Common denominator is UTHR. Hopefully they can bypass all of that, like the Tyvaso product line, and follow the same route...with UTHR again. Maybe UTHR is more experienced at putting those together. But, the kicker is that Clofazamine is MNKDs product, whereas Tyvaso was UTHRs. Was that correct?
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Post by cretin11 on Oct 30, 2023 14:33:06 GMT -5
No doubt UTHR is more experienced at it, hopefully we can work with them on this product. Would love to see an announcement of that, surely it would give our share price a boost and hopefully a sustainable one.
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Post by MnkdWASmyRtrmntPlan on Oct 30, 2023 15:07:19 GMT -5
Maybe working more with UTHR would encourage them to just buy MNKD.
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Post by olebob1 on Oct 30, 2023 15:18:58 GMT -5
Maybe working more with UTHR would encourage them to just buy MNKD. What would you need for a premium?
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Post by MnkdWASmyRtrmntPlan on Oct 30, 2023 15:23:19 GMT -5
Ha, my answer to that is ... how much do they got? I'm sure UTHR has enough cash to satisfy us. ;o) Unfortunately, they just bought another company today, but maybe they can go on a buying spree.
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Post by cretin11 on Oct 30, 2023 16:13:42 GMT -5
They paid a 170% premium for MIRO, a robust premium. Pretty sure it's a moot point (I still think if UTHR wanted us it would've happened a while back), but we probably couldn't reasonably expect higher than 170% regardless of the buyer.
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Post by castlerockchris on Oct 30, 2023 20:34:36 GMT -5
I would take 170% premium but I highly doubt UTHR would pay that. Maybe they would if it were a cash and stock deal, but still not likely. I wouldn’t take anything less than 9 at this point. I can wait until late 2024 to get to 9 or 10. 🤞
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