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Post by prcgorman2 on Mar 21, 2023 17:21:43 GMT -5
There is money to be made in the US if Afrezza in India is approved which was the point of the trial if I remember correctly. The margin may be next to non-existent but should help amortize or defray production costs.
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Post by cretin11 on Mar 21, 2023 18:01:19 GMT -5
What do you think the placebo is? Peppy - as Aged said this is the exact same study as Affinity 2 and will show the exact same result - afrezza will show superiority. Whether the superiority will be superior to Affinity 2 depends on the dosing. I doubt its different and it says nothing about follow-up dosing. All I hope is MNKD is not paying any money to support this trial. IMO, this study is a complete waste of time with the exception to check the box in India. Then again, as Mike has said and has been said on this board in the past there is no money to be made in India. I haven’t paid close attention, but if MNKD is paying no money to support this trial, who is funding it?
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Post by rayskum on Mar 21, 2023 18:40:12 GMT -5
Peppy - as Aged said this is the exact same study as Affinity 2 and will show the exact same result - afrezza will show superiority. Whether the superiority will be superior to Affinity 2 depends on the dosing. I doubt its different and it says nothing about follow-up dosing. All I hope is MNKD is not paying any money to support this trial. IMO, this study is a complete waste of time with the exception to check the box in India. Then again, as Mike has said and has been said on this board in the past there is no money to be made in India. I haven’t paid close attention, but if MNKD is paying no money to support this trial, who is funding it? Hope Cipla is taking the tab
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Post by mnkdfann on Mar 21, 2023 22:42:22 GMT -5
The analysts have access to the same information we do and their estimate for next year is fifteen cents a share. Where do you find $0.15 as the next year EPS prediction? At SA, I see -$0.14 (a loss next year). At CNBC, I see -$0.18 (a loss next year). The two research reports at my online Brokerage also show negative EPS predictions for next year.
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Post by porkini on Mar 21, 2023 23:36:46 GMT -5
The analysts have access to the same information we do and their estimate for next year is fifteen cents a share. Where do you find $0.15 as the next year EPS prediction? At SA, I see -$0.14 (a loss next year). At CNBC, I see -$0.18 (a loss next year). The two research reports at my online Brokerage also show negative EPS predictions for next year. Links please, or it didn't happen!
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Post by neil36 on Mar 22, 2023 6:49:18 GMT -5
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Post by Clement on Mar 22, 2023 8:19:50 GMT -5
Please note: On the above Yahoo Finance page, current year is 2023. Next year is 2024. As Neil said, "their estimate for next year is fifteen cents a share."
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Post by neil36 on Mar 22, 2023 8:30:35 GMT -5
I find it particularly interesting that the next year revenue estimates range from a low of $213 million to a high of $346 million. That is a huge disparity in models.
Being the eternal optimist, I'm hoping we end up near the high estimate, which comes with a projected thirty-one cent earnings. A growth rate like that would warrant a very juicy PE/PEG ratio, and yes, a double-digit stock price.
But I've been here long enough to know to meter my expectations.
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Post by Clement on Mar 22, 2023 8:47:05 GMT -5
I haven’t paid close attention, but if MNKD is paying no money to support this trial, who is funding it? Hope Cipla is taking the tab Cipla pays for it. 2018 press release. "Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza® in India, including approval from the Drug Controller General of India. Cipla will also be responsible for all marketing and sales activities of Afrezza in India. MannKind is responsible for supplying Afrezza to Cipla." investors.mannkindcorp.com/news-releases/news-release-details/mannkind-and-cipla-enter-exclusive-marketing-and-distribution
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Post by uvula on Mar 22, 2023 9:31:30 GMT -5
Almost 5 years ago. How much longer before the first dose is sold in India?
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Post by prcgorman2 on Mar 22, 2023 9:32:40 GMT -5
Almost 5 years ago. How much longer before the first dose is sold in India? Hopefully not much longer assuming another global pandemic doesn't interfere AGAIN.
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Post by hopingandwilling on Mar 22, 2023 9:50:48 GMT -5
FYI:
The Cipla deal was done five years ago. The Brazil deal was done years ago---and they haven't purchased any Afrezza in more than two years ago. The "supposed" clinic trial was designed for a little over 200 patients--18-65 years of age. The "supposed" clinic trial was designed to last for 24 weeks for those patients enlisted in the trial
FYI: Cipla has a website for their corporation. On their website they have a search link. Put in the word Afrezza and it tells you they have no references for this topic.
They is something about this deal that doesn't match up with Cipla really having any interest in spending their money on developing Afrezza for India. I hope I'm wrong!
With five years passing and they can't find 200 patients in of all places--India with a zillion citizens there is something "rotten in Denmark and now India"
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Post by prcgorman2 on Mar 22, 2023 9:59:04 GMT -5
Trials take years. India was hit hard by COVID. I don't care what CIPLA web developers make available on their website with regard to a drug under trial. I think there is something that doesn't match up with your posts.
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Post by agedhippie on Mar 22, 2023 11:06:40 GMT -5
FYI: The Cipla deal was done five years ago. The Brazil deal was done years ago---and they haven't purchased any Afrezza in more than two years ago. The "supposed" clinic trial was designed for a little over 200 patients--18-65 years of age. The "supposed" clinic trial was designed to last for 24 weeks for those patients enlisted in the trial FYI:Cipla has a website for their corporation. On their website they have a search link. Put in the word Afrezza and it tells you they have no references for this topic. They is something about this deal that doesn't match up with Cipla really having any interest in spending their money on developing Afrezza for India. I hope I'm wrong! With five years passing and they can't find 200 patients in of all places--India with a zillion citizens there is something "rotten in Denmark and now India" A lot of FYIs there - BIOMM have suspended Afrezza purchases. Their minutes say it's temporary but I suspect not. I think that deal is dead. - The India clinical trial exists and is registered in the CTRI database - ctri.nic.in/Clinicaltrials/showallp.php?mid1=45751&EncHid=&userName=Cipla - The data was last updated at the start of the year and is active with 216 people. - The trial is paid for by Cipla. From the SEC filings: " Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla." Clinical trials take time. People are started as they sign up and pass the vetting criteria defined in the trial filing. The result is that a 24 week trial can easily last a few years (you can see this even with the big pharma drug trials) It's likely that COVID imposed delays as well, it certainly did with US clinical trials.
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Post by peppy on Mar 22, 2023 11:25:35 GMT -5
Trials take years. India was hit hard by COVID. I don't care what CIPLA web developers make available on their website with regard to a drug under trial. I think there is something that doesn't match up with your posts. Trials take years. That is the bill of goods we have been sold. One exception to the rule are the psych / depression/ meds. DSM diagnostic numbers some drug trials have lasted only weeks. Some are very bad drugs, designed to help a person to stop thinking. Just sayin. Buyer beware.
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