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Post by dreamboatcruise on Jun 5, 2018 16:32:06 GMT -5
It's better than buying from the open market. Money goes directly to company's coffer. Yeah, somewhat. It's basically adding to the ATM but without needing shareholder approval to do so. From an employees perspective I think I'd rather time my buys in the open market rather than agreeing to purchase at market price on some date in the future. Especially if the stock starts climbing upward, delaying the purchase would mean you pay higher than when you have committed to the purchase.
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Post by dreamboatcruise on Jun 5, 2018 16:25:10 GMT -5
According to Steadymed PR they believe it will be approved by end of this year. It is cumbersome having a pump attached, but a steady infusion might provide better results than periodic dry powder dosing ? ? I would assume (and backed by medical professional surveys cited by Steadymed) that this pump system will gain market share rapidly from the other available treatments such as the nebulizer. So by the time TreT hits the market that may be the SOC... or on its way. ...believe...might...assume...may... Other than those words burried in this paragraph, it seems quite factual. 🙃 I think it less factual without those words. Adding in those words in fact makes it more factual. I too often see people here stating speculation as fact without stating that it is someone's belief or expectation rather than a certainty. Though I also gather that some here simply think things should always be stated as certainties or not discussed at all... or state the good for MNKD with certainty and question anything less than good. In the case of Steadymed, according to the PR this is the plan agreed to by the FDA. So I'd at least put the certainty level on the same footing as MNKD's accelerated timeline that was based on its meetings with FDA. But yes, the "true long" way of looking at this would be to imply absolute certainty for MNKD's schedule and question the same for Steadymed. Based on MNKD and Steadymed, I wouldn't be surprised if Liquidia isn't trying to work out some sort of accelerated process with FDA. It seems FDA has taken a position that PAH is in dire need of new options and thus expediting the process for new Trep options. Perhaps there is a reason Liquidia should be treated differently, but it is curious.
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Post by dreamboatcruise on Jun 5, 2018 16:18:48 GMT -5
Perhaps it is as simple as MNKD making a move to look and smell more like a real corporate entity. If I were an employee, I would like the option to buy in house. My brief stints with large corporations have had stock purchase plans but with a discount. If there is no discount, there isn't really an advantage to the employee. I believe one of the plans I had many years ago was something like once a quarter there was a purchase date. We got 15% discount to the lower the average over the past quarter or the market price on the purchase date. That was a sweet deal because one could always turn around and sell at a profit. Though I might be conflating terms from 2 plans I've participated in long ago. Perhaps to offer a discount it must be approved by shareholders.
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Post by dreamboatcruise on Jun 5, 2018 16:09:52 GMT -5
Very interesting. It would appear that insiders need a faster and easier way to purchase MannKind stock at current market value. At the ASM, Dr. Kendall mentioned that he would be buying shares as soon as the Legal Department would let him. This new program appears to open the door for him to do that. I think this is a positive. I am not an expert, but I think deferred payment is an option. Meaning, someone could "purchase" a quantity of stock and pay it off over a period of time. That could be the benefit of this plan? The plan documents seems to indicate money is withheld from salary ahead of purchase date since it talks about accruing it in the accounting system and crediting it back to employee if for some reason the purchase does not occur.
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Post by dreamboatcruise on Jun 5, 2018 16:07:38 GMT -5
United Therapeutics bought Steadymed Ltd. for $216M. They have a TREVYENT (Dev. Stage) which is a Patch/Pump Device for PAH. United Therapeutics To Acquire SteadyMed Ltd. SILVER SPRING, Md. and SAN RAMON, Calif., April 30, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) and SteadyMed Ltd. (NASDAQ: STDY) announced today the signing of a definitive merger agreement under which United Therapeutics will acquire SteadyMed for $4.46 per share in cash at closing and an additional $2.63 per share in cash upon the achievement of a milestone related to the commercialization of Trevyent®. The transaction, including the $75 million in contingent consideration, is valued at $216 million. SteadyMed is a specialty pharmaceutical company focused on the development and commercialization of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs. SteadyMed's product portfolio includes Trevyent, a development-stage drug-device combination product that combines SteadyMed's two day, single use, disposable PatchPump® technology with treprostinil, a vasodilatory prostacyclin analogue, for the subcutaneous treatment of pulmonary arterial hypertension (PAH). United Therapeutics is a leading biotechnology company focused on the development and commercialization of therapies for the treatment of PAH and other orphan diseases. "We are optimistic about acquiring SteadyMed and adding Trevyent to our pipeline of products to treat PAH," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We are especially impressed with SteadyMed's management team and global supply chain. Trevyent fits in well with our mission, and we look forward to bringing the product to the maximum number of patients as soon as possible." "United Therapeutics has always been at the forefront of developing therapies to treat PAH, and we are delighted at the prospect of our companies coming together, as one, to continue that mission," said Jonathan M.N. Rigby, President and Chief Executive Officer of SteadyMed. "We believe that this proposed acquisition will help us realize our commitment to bring Trevyent to market to improve the lives of patients with PAH." According to Steadymed PR they believe it will be approved by end of this year. It is cumbersome having a pump attached, but a steady infusion might provide better results than periodic dry powder dosing ? ? I would assume (and backed by medical professional surveys cited by Steadymed) that this pump system will gain market share rapidly from the other available treatments such as the nebulizer. So by the time TreT hits the market that may be the SOC... or on its way.
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Post by dreamboatcruise on Jun 5, 2018 14:48:51 GMT -5
I am more excited by STAT rather than a reworking of the hypo data. peppy ... no, MNKD has not had a trial with CGM in the past.It has already been presented that Afrezza achieved statistically significant reduction in total hypos, with slightly worse but deemed non inferior A1c. Severe hypos were less but deemed not statistically significant because of small study size and thus very infrequent severe hypos in either arm. If they are simply reworking this data, I don't think it will be considered a show stopper. But I'm holding off judgement, as I really don't know what they have up their sleeve. To clarify, has ANY insulin trial used CGM to date dream? Is this the first trial ever looking at insulins and comparing them using continuous glucose monitors, dream? Geez louise. Lizards have very tiny brains I assume Dexcom had to do trials to get approved to be used for dosing, comparing an arm using finger stick to an arm using CGM. I know I remember some trial that made use of blinded CGM. I did quick google and turned up these articles. www.ncbi.nlm.nih.gov/pmc/articles/PMC3192633/www.ncbi.nlm.nih.gov/pmc/articles/PMC5038541/
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Post by dreamboatcruise on Jun 5, 2018 14:32:40 GMT -5
I am more excited by STAT rather than a reworking of the hypo data. peppy... no, MNKD has not had a trial with CGM in the past. It has already been presented that Afrezza achieved statistically significant reduction in total hypos, with slightly worse but deemed non inferior A1c. Severe hypos were less but deemed not statistically significant because of small study size and thus very infrequent severe hypos in either arm. If they are simply reworking this data, I don't think it will be considered a show stopper. But I'm holding off judgement, as I really don't know what they have up their sleeve.
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Post by dreamboatcruise on Jun 5, 2018 14:21:52 GMT -5
So we have the huge nebulizer that seems to have never started clinical trials, and liquidia which is ahead of mnkd and could be just as effective as the mnkd drug. Sounds like we could be a few years late. Nope. The MannKind trepostinil Phase 1 trial will be completed December 2018 and the Phase 3 has been estimated by CMO David Kendall MD to be complete in late 2019, which puts it slightly ahead of Liquidia's, whose clinical trial for LIQ861 has an estimated study completion date of July 2020.
MannKind anticipates filing its NDA by mid-2020 while Liquidia will only have just completed its safety study. Also, the LIQ861 has only one Primary Outcome related to adverse events and seriously adverse events. MannKind's will have a full PK study data completed in 2019.
What's going on with the FDA, giving MNKD preferential treatment... do they perhaps feel guilty about SOMETHING
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Post by dreamboatcruise on Jun 5, 2018 14:09:49 GMT -5
The counter to that is going to be that it was achieved at the cost of a worse HbA1c outcome and that if the RAA arm had similarly underperformed their hypo rate would also be lower. That said I don't see a poster having a lot of impact, they need to get this published in a journal. 100% agree with getting the data published, but I don't see how you can assume a worse HbA1c outcome unless you see all the data. It's quite possible that the analysis filtered out doses taken too soon before mealtime, for example. We'll all have to wait to see what they Kendall and the SAB did with the data, I think. Yes, wait and see. I'm very curious about the "adjustment" that is referenced. In general, however, retrospectively massaging data to present an outcome isn't viewed nearly as highly in medical world as prospective outcome measures built into the study design at the start... if indeed what you are suggesting is the type of "adjustment" being done.
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Post by dreamboatcruise on Jun 5, 2018 14:00:23 GMT -5
Im not sure i understand this. What is the advantage for the employees to buy those shares if it is at the same price as the market? They could have bought at this price for the last 2 months and 6 months in 2017. They had all the time they needed if they wanted to buy. Is there any advantage for the company? Im not getting the point. I haven't gone over the details with a fine tooth comb, but I presume these shares are coming direct from Mannkind so Mannkind gets the cash. Whereas if the shares were bought by the employees on the open market, Mannkind would get nothing out of it. It also says that 1.94 is the maximum offering price, so the shares might still be issued for less. Yes, direct from MNKD as this is a registration statement... i.e. new to the market shares. If it is at the market, and there isn't some hidden discount built in (still uncertain about this "max price"), then it would seem this is primarily to allow employees to do purchasing in a way that contributes a little to funding the company.
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Post by dreamboatcruise on Jun 5, 2018 13:55:56 GMT -5
So we have the huge nebulizer that seems to have never started clinical trials, and liquidia which is ahead of mnkd and could be just as effective as the mnkd drug. Sounds like we could be a few years late. Tyvaso is approved. Interesting to the earlier question about dosing frequency. According to the following from Liquidia, Tyvaso does have some issue that limits the maximum tolerable dose below what can be delivered with Liquidia inhaler (50% more). Perhaps MNKD can best even that, and thereby extend the interval between dosing. liquidia.com/wp-content/uploads/2016/10/Liquidia-LIQ861-PVRI-Poster-FINAL-20180124.pdf
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Post by dreamboatcruise on Jun 5, 2018 13:44:01 GMT -5
DBC, would you're presumption about a BP for MNKD still hold if they beat Liquidia to market as mnholdem presented above? Thanks. Didn't see that. A bit surprising that would be the case, but I'd still think the best course would be finding a partner even just knowing one of the BP were reasonably close behind. Better to have hefty marketing muscle to dominate before the real competition arrives. But MNKD would certainly stand a better chance going it alone if they were first with dry powder rather than second.
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Post by dreamboatcruise on Jun 5, 2018 13:27:36 GMT -5
Perhaps someone that is more familiar with SEC filings could explain about the purchase. It seems a max price is set based on May 29th ($1.94). Yet it seems from the plan document the shares will actually be sold at market price over an extended period of time. Does this mean if an employee signs up to purchase and the share price is above $1.94 on their designated purchase date that the transaction does not happen and the employees money is returned? That seems strange to have a max price if it is supposed to be at the market. Or is that max price listed for the SEC, something that isn't set in stone or simply updated if it is exceeded?
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Post by dreamboatcruise on Jun 5, 2018 13:21:48 GMT -5
I suspect employees have asked about such a program as those who are dedicated to the company may want to be part of possible future gains. It's a nice program to offer in any case. It is a good thing to do and I do now see it as a concern as far as major dilution unless I am missing something here. It's an additional 2M shares. A year ago that might have seemed large, but with the level of shares that have been created and obligated since, it starts looking small.
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Post by dreamboatcruise on Jun 5, 2018 13:00:55 GMT -5
Thanks... not much difference between Liquidia and dreamboat. TreT would unlikely use the dreamboat, but rather one of the myriad other designs MNKD shows on their website. The nebulizer seems like it would lose out as soon as Liquidia's hits the market. I think there is usually room for more than one brand, but if Glaxo has success with Liquidia it would mean MNKD is going to have to have a BP pick it up to compete properly.
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