|
|
Post by Thundersnow on Oct 27, 2022 8:58:04 GMT -5
It's been over 10 years whereby I have never agreed with Kevinmik. We all know how he is so I will not expand
BUT for the first time EVER I agree with his analysis.
I believe UTHR and MNKD are working on a DPI for Ralinepag.
I have been trying to figure out why UTHR has not signed up a new molecule
and about 3 months ago I said I wonder if they are going to make Ralinepag a DPI.
Makes sense and it would be a BLOCKBUSTER (assuming it gets FDA Approval).
His Analysis: United Therapeutic did a huge deal $1.2 billion with Arena Pharma in 2018, buying the rights for Ralinepag to treatment PAH. United initiated Phase III Clinical Trial for Ralinepag began in August 2018, recruiting 700 patients and it's expected to be completed in December 2022. United may now be ready to start testing Ralinepag as an inhaled drug, which could include MNKD under the 2018 Research Agreement MNKD signed with United. MNKD could do a feasibility study. If MNKD is given the Ralinepag deal for inhalation delivery, it will trigger a $30 million payment under the 2018 Research Agreement and double digit royalties on net sales. Pfizer bought Arena and is now United partner
And I believe UTHR paid over $2 BILLION for Ralinepag.
Any comments???
|
|
|
|
Post by Clement on Oct 27, 2022 9:23:29 GMT -5
Copy of an old post from Feb 10, 2019: "Ralinepag phase 2 post hoc analysis Feb 10, 2019 at 9:05am goyocafe, sportsrancho, and 2 more like thisQuoteEditPost OptionsPost by Clement on Feb 10, 2019 at 9:05am Presented at the 2018 American Thoracic Society International Conference, San Diego, California; May 18–23, 2018 www.arenapharm.com/wp-content/uploads/2018/05/ATS-Ralinepag-Plasma-Levels-Correlate-w-Improvements-in-Functional-and-Hemo-Parameters.pdfThis poster shows that oral ralinepag improves pulmonary vascular resistance and the 6 minute walking distance. OK. Cool. But let's look at some interesting numbers. In this poster, Table 1 says that the ralinepag group has n=40 patients. Next, Figure 2A indicates that 30% of ralinepag patients had 0.4 mg Dose at End of Maintenance Phase. Now, in Figure 2B shows plasma concentrations for those 12 patients having a Last Total Daily Dose of 0.4 mg. We see that the range of values for plasma level go from about 4 ng/mL up to 24 ng/mL. That is a wide range. Even if you remove the min and max you get a wide range of values. My speculation: If plasma levels could have a tighter range, perhaps patient response could be more consistent and therefore the results would be even more improved. This appears to be a good drug which might be significantly better with some other delivery method. Maybe Technosphere. (For those new to the Mannkind story: MNKD has contractual ties to UTHR. UTHR has a recent licensing agreement with Arena concerning ralinepag. According to this agreement, UTHR can pay an additional amount to develop an inhaled version. I think this poster (discussed above) might help us understand why UTHR would want to develop an inhaled version.)" |
|
|
|
Post by cjm18 on Oct 27, 2022 9:43:20 GMT -5
|
|
|
|
Post by cjm18 on Oct 27, 2022 9:50:04 GMT -5
|
|
|
|
Post by agedhippie on Oct 27, 2022 11:18:28 GMT -5
... Now, in Figure 2B shows plasma concentrations for those 12 patients having a Last Total Daily Dose of 0.4 mg. We see that the range of values for plasma level go from about 4 ng/mL up to 24 ng/mL. That is a wide range. Even if you remove the min and max you get a wide range of values. My speculation: If plasma levels could have a tighter range, perhaps patient response could be more consistent and therefore the results would be even more improved. This appears to be a good drug which might be significantly better with some other delivery method. Maybe Technosphere. It's unlikely, but not impossible this might be developed. A major part of the value proposition for Ralinepag is that it is a pill and unlike other oral prostacyclin drugs it has high bioavailability and a long half-life in it's XR form (the XR fixes the range fluctuation). I am curious what the benefit of an inhaled version would be over a pill since that seems to be the USP of Ralinepag. |
|
|
|
Post by prcgorman2 on Oct 27, 2022 11:19:33 GMT -5
I like the title of this thread. A famous Illinois politician was quoted as saying, "A billion here, a billion there, pretty soon you're talking real money." Fingers crossed for a $30M research payout and double-digit royalties on another UTHR PAH drug.
|
|
|
|
Post by peppy on Oct 27, 2022 11:41:28 GMT -5
It's been over 10 years whereby I have never agreed with Kevinmik. We all know how he is so I will not expand BUT for the first time EVER I agree with his analysis. I believe UTHR and MNKD are working on a DPI for Ralinepag. I have been trying to figure out why UTHR has not signed up a new molecule and about 3 months ago I said I wonder if they are going to make Ralinepag a DPI. Makes sense and it would be a BLOCKBUSTER (assuming it gets FDA Approval). His Analysis: United Therapeutic did a huge deal $1.2 billion with Arena Pharma in 2018, buying the rights for Ralinepag to treatment PAH. United initiated Phase III Clinical Trial for Ralinepag began in August 2018, recruiting 700 patients and it's expected to be completed in December 2022. United may now be ready to start testing Ralinepag as an inhaled drug, which could include MNKD under the 2018 Research Agreement MNKD signed with United. MNKD could do a feasibility study. If MNKD is given the Ralinepag deal for inhalation delivery, it will trigger a $30 million payment under the 2018 Research Agreement and double digit royalties on net sales. Pfizer bought Arena and is now United partner And I believe UTHR paid over $2 BILLION for Ralinepag. Any comments??? Not on stock twits and I do not read Kevin. Years ago it was posted here, Kevin was sure AMGN was going to buy MNKD; secondary to Castagna coming from Amgen, Kendall, etc, etc. There were threads on the subject. No go. |
|
|
|
Post by cretin11 on Oct 27, 2022 11:50:08 GMT -5
It's been over 10 years whereby I have never agreed with Kevinmik. We all know how he is so I will not expand BUT for the first time EVER I agree with his analysis. I believe UTHR and MNKD are working on a DPI for Ralinepag. I have been trying to figure out why UTHR has not signed up a new molecule and about 3 months ago I said I wonder if they are going to make Ralinepag a DPI. Makes sense and it would be a BLOCKBUSTER (assuming it gets FDA Approval). His Analysis: United Therapeutic did a huge deal $1.2 billion with Arena Pharma in 2018, buying the rights for Ralinepag to treatment PAH. United initiated Phase III Clinical Trial for Ralinepag began in August 2018, recruiting 700 patients and it's expected to be completed in December 2022. United may now be ready to start testing Ralinepag as an inhaled drug, which could include MNKD under the 2018 Research Agreement MNKD signed with United. MNKD could do a feasibility study. If MNKD is given the Ralinepag deal for inhalation delivery, it will trigger a $30 million payment under the 2018 Research Agreement and double digit royalties on net sales. Pfizer bought Arena and is now United partner And I believe UTHR paid over $2 BILLION for Ralinepag. Any comments??? Not on stock twits and I do not read Kevin. Years ago it was posted here, Kevin was sure AMGN was going to buy MNKD; secondary to Castagna coming from Amgen, Kendall, etc, etc. There were threads on the subject. No go. Amazingly i actually agree with peppy on something. The next time kevinmik is right about a prediction will be the first time. His posts are at least entertaining in that he's not only wrong, but he's usually WAY off target. And he deserves credit for his active imagination at coming up with predictions. But there's another old saying, "there's a first time for everything" and who knows, this might be the time kevinmik finally gets to say "i told you so!" |
|
|
|
Post by peppy on Oct 27, 2022 12:14:06 GMT -5
Not on stock twits and I do not read Kevin. Years ago it was posted here, Kevin was sure AMGN was going to buy MNKD; secondary to Castagna coming from Amgen, Kendall, etc, etc. There were threads on the subject. No go. Amazingly i actually agree with peppy on something. The next time kevinmik is right about a prediction will be the first time. His posts are at least entertaining in that he's not only wrong, but he's usually WAY off target. And he deserves credit for his active imagination at coming up with predictions. But there's another old saying, "there's a first time for everything" and who knows, this might be the time kevinmik finally gets to say "i told you so!" said Ralinepag is oral, a pill. cdn.caymanchem.com/cdn/insert/30009.pdfLooks like a protein. Interesting Ralinepag is soluble in ethanol. There s another product I know of that uses ethanol to be extracted. Aged? do you know it? |
|
|
|
Post by nylefty on Oct 27, 2022 17:23:30 GMT -5
I like the title of this thread. A famous Illinois politician was quoted as saying, "A billion here, a billion there, pretty soon you're talking real money." Fingers crossed for a $30M research payout and double-digit royalties on another UTHR PAH drug. |
|
|
|
Post by prcgorman2 on Oct 27, 2022 18:50:10 GMT -5
I like the title of this thread. A famous Illinois politician was quoted as saying, "A billion here, a billion there, pretty soon you're talking real money." Fingers crossed for a $30M research payout and double-digit royalties on another UTHR PAH drug. Yup. I should have said “was mis-quoted as saying...”. |
|
|
|
Post by bones1026 on Oct 27, 2022 20:17:54 GMT -5
Not on stock twits and I do not read Kevin. Years ago it was posted here, Kevin was sure AMGN was going to buy MNKD; secondary to Castagna coming from Amgen, Kendall, etc, etc. There were threads on the subject. No go. Amazingly i actually agree with peppy on something. The next time kevinmik is right about a prediction will be the first time. His posts are at least entertaining in that he's not only wrong, but he's usually WAY off target. And he deserves credit for his active imagination at coming up with predictions. But there's another old saying, "there's a first time for everything" and who knows, this might be the time kevinmik finally gets to say "i told you so!" I don’t agree with either of you..although he can seem bipolar, I’d listen to what he has to say, compared to your constant negative rebuttals. Nobody can ever say that guy doesn’t do his research..almost to a fault at times |
|
|
|
Post by cretin11 on Oct 28, 2022 9:19:49 GMT -5
Amazingly i actually agree with peppy on something. The next time kevinmik is right about a prediction will be the first time. His posts are at least entertaining in that he's not only wrong, but he's usually WAY off target. And he deserves credit for his active imagination at coming up with predictions. But there's another old saying, "there's a first time for everything" and who knows, this might be the time kevinmik finally gets to say "i told you so!" I don’t agree with either of you..although he can seem bipolar, I’d listen to what he has to say, compared to your constant negative rebuttals. Nobody can ever say that guy doesn’t do his research..almost to a fault at times Just curious, why would you “listen to what he has to say” when his predictions are off base close to 100% of the time? And admittedly I haven’t read all his posts, so maybe I’ve missed some correct predictions, can you point to any? I’d rather read “constant negative rebuttals” that are factual and accurate than constant delusional predictions, but YMMV. I agree with you that he does research, but the conclusions he draws and the dots he connects are farcical. |
|
|
|
Post by Thundersnow on Oct 28, 2022 10:09:23 GMT -5
I don’t agree with either of you..although he can seem bipolar, I’d listen to what he has to say, compared to your constant negative rebuttals. Nobody can ever say that guy doesn’t do his research..almost to a fault at times Just curious, why would you “listen to what he has to say” when his predictions are off base close to 100% of the time? And admittedly I haven’t read all his posts, so maybe I’ve missed some correct predictions, can you point to any? I’d rather read “constant negative rebuttals” that are factual and accurate than constant delusional predictions, but YMMV. I agree with you that he does research, but the conclusions he draws and the dots he connects are farcical. That is very true. Even though Kevinmik loves to write HE IS WRONG 100% of the time. His "THEORIES" are way off base. I'm so glad he's not a CEO of a company. It's also strange he does not write about any other stock EXCEPT MNKD. He has an obsession with MNKD and never writes about buying or selling his shares. We don't even know if he OWNS MNKD Shares. |
|
|
|
Post by hellodolly on Oct 28, 2022 13:04:57 GMT -5
Just curious, why would you “listen to what he has to say” when his predictions are off base close to 100% of the time? And admittedly I haven’t read all his posts, so maybe I’ve missed some correct predictions, can you point to any? I’d rather read “constant negative rebuttals” that are factual and accurate than constant delusional predictions, but YMMV. I agree with you that he does research, but the conclusions he draws and the dots he connects are farcical. That is very true. Even though Kevinmik loves to write HE IS WRONG 100% of the time. His "THEORIES" are way off base. I'm so glad he's not a CEO of a company. It's also strange he does not write about any other stock EXCEPT MNKD. He has an obsession with MNKD and never writes about buying or selling his shares. We don't even know if he OWNS MNKD Shares. And, we don't know how many screen names he's using. I use to waste my time addressing his comments until I figured I can't ever get those days back, so I'm not going to let it happen again. |
|
