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Post by joeypotsandpans on Sept 7, 2018 14:44:29 GMT -5
Remember the term "the Bernanke Put" well that was to put a floor on the market and give investors the confidence to re-enter the markets and clearly gave a buy signal to the fund managers etc. The UTHR Put as I will refer to it is essentially the same idea regarding the buy side of this equity. IMO a "floor" has been established and solidified with Tuesday's announcement regarding the cash injection and potential cash inflows from the remaining milestones and royalties. Although I already have a fairly large core position, I purchased 20K (with trading partner so really 10K each) trading shares this morning at 1.71 which will be used to buy on any dips. I believe with the UTHR announcement that any dips will now be bought and the existing short shares will compete with new buyers looking to establish long positions. IMO this should be a buy the dip and sell the rip equity for a buy side bias going forward for trading shares only. If you are not trading any shares and have a core long position then you know what the longer term positives are for the company at this point. One caveat to the UTHR situation is that I believe there is the potential for LQDA to add a possible objection into the FTC mix, after all they are left standing alone at the alter now with what looks to be an inferior product, at worst I would expect that UTHR might have to divest some of their stranglehold on the PAH market if it is deemed there is an anti-trust issue. I am expecting/suspect that FUD to come into play while the 30 day period is in effect. In the end however, UTHR married with the right partner and it should be a win-win for both parties going forward. Could it have been a better deal had the company been in a different position, absolutely, but the more important aspect is the overwhelming vote of confidence UTHR displayed in Technosphere with the additional research request. Enjoy your weekends  |
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Post by cedafuntennis on Sept 7, 2018 15:38:22 GMT -5
Is there a possibility for UHR to renege on this agreement with MNKD if the government throws any objections? Would this deal be more important to them than divesting of a few existing PAH assets?
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Post by mannmade on Sept 7, 2018 15:55:35 GMT -5
Only a guess on my part but am sure they have contingencies for that event which they must judge as remote. Also UTHR seems to have an underlying interest in TS judging by the quick follow up to start and pay for research on other molecules. With that in mind I don’t see them walking away very easily. Just my opinion.
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Post by joeypotsandpans on Sept 7, 2018 15:55:40 GMT -5
Is there a possibility for UHR to renege on this agreement with MNKD if the government throws any objections? Would this deal be more important to them than divesting of a few existing PAH assets? With the idea that TT (as opposed to TI) can show more effective dosing along with any other advantages, it would behoove UTHR to seize the opportunity to take the "advanced treatment" over existing rather than let some other company get their hands on it. So it really comes down to what future value UTHR projects the technosphere application to potentially bring to the table. If it outweighs/obsoletes a more barbaric treatment (borrowing our illustrious Dr. K's terms relative to current insulin treatments) of PAH treatments that UTHR currently has, they should be able to make a case for it not just from a cost/benefit standpoint but to the FTC as well IMO. I want to add something here as well regarding the long term manufacturing aspect with respect to UTHR taking that part of the equation and welcome thoughts and/or opinions regarding same. If Mike felt like the international sales are on the verge of coming through (within a couple of quarters Brazil/India and others) along with increased US sales of Afrezza, I am not so sure that he wasn't satisfied with the deal and keeping the lines available for strictly Afrezza production. The cash and future royalties along with the intrinsic value of the deal reaffirming/validating Technosphere in the biotech community was far more important on this first partnership than getting the manufacturing portion as part of the deal, was thinking about this the past couple of days and made sense to me. Just thinking out loud on this aspect of the deal. |
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Post by jlaw277 on Sept 7, 2018 16:21:44 GMT -5
Only a guess on my part but am sure they have contingencies for that event which they must judge as remote. Also UTHR seems to have an underlying interest in TS judging by the quick follow up to start and pay for research on other molecules. With that in mind I don’t see them walking away very easily. Just my opinion. I think the FTC would have a hard time making an anti-trust objection to a deal for a drug/delivery mechanism that has yet to go through Phase 3 trials. Plus, MNKD has no percentage of that market now, only a possibly superior delivery mechanism. I say "possibly" only because it hasn't earned approval as of yet. I also think you are right regarding the additional UTHR interest in other applications. Reading more about Rothblatt, it is clear that she is deeply interested in the subject of organ transplant and even organ manufacturing where there seems to be other possible applications for TI. I like the idea of the UTHR put and think it has real merit. |
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Post by rockstarrick on Sept 7, 2018 17:28:16 GMT -5
Only a guess on my part but am sure they have contingencies for that event which they must judge as remote. Also UTHR seems to have an underlying interest in TS judging by the quick follow up to start and pay for research on other molecules. With that in mind I don’t see them walking away very easily. Just my opinion. I think the FTC would have a hard time making an anti-trust objection to a deal for a drug/delivery mechanism that has yet to go through Phase 3 trials. Plus, MNKD has no percentage of that market now, only a possibly superior delivery mechanism. I say "possibly" only because it hasn't earned approval as of yet. I also think you are right regarding the additional UTHR interest in other applications. Reading more about Rothblatt, it is clear that she is deeply interested in the subject of organ transplant and even organ manufacturing where there seems to be other possible applications for TI. I like the idea of the UTHR put and think it has real merit. It will be interesting to see just what trials are required for an “already approved drug delivery device” combined with an “already approved drug” ?? Anybody have any ideas on what might be required. 😎 |
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Post by mango on Sept 7, 2018 17:33:29 GMT -5
I think the FTC would have a hard time making an anti-trust objection to a deal for a drug/delivery mechanism that has yet to go through Phase 3 trials. Plus, MNKD has no percentage of that market now, only a possibly superior delivery mechanism. I say "possibly" only because it hasn't earned approval as of yet. I also think you are right regarding the additional UTHR interest in other applications. Reading more about Rothblatt, it is clear that she is deeply interested in the subject of organ transplant and even organ manufacturing where there seems to be other possible applications for TI. I like the idea of the UTHR put and think it has real merit. It will be interesting to see just what trials are required for an “already approved drug delivery device” combined with an “already approved drug” ?? Anybody have any ideas on what might be required. 😎 More than likely these clinical trials will be just like the one currently ongoing with TreT. Short safety/equivalency/generic drug trials Phase 1 -> Phase 3 I am curious if MannKind will do any biosimilars either for themselves or for UT |
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Post by mango on Sept 7, 2018 17:34:51 GMT -5
Remember the term "the Bernanke Put" well that was to put a floor on the market and give investors the confidence to re-enter the markets and clearly gave a buy signal to the fund managers etc. The UTHR Put as I will refer to it is essentially the same idea regarding the buy side of this equity. IMO a "floor" has been established and solidified with Tuesday's announcement regarding the cash injection and potential cash inflows from the remaining milestones and royalties. Although I already have a fairly large core position, I purchased 20K (with trading partner so really 10K each) trading shares this morning at 1.71 which will be used to buy on any dips. I believe with the UTHR announcement that any dips will now be bought and the existing short shares will compete with new buyers looking to establish long positions. IMO this should be a buy the dip and sell the rip equity for a buy side bias going forward for trading shares only. If you are not trading any shares and have a core long position then you know what the longer term positives are for the company at this point. One caveat to the UTHR situation is that I believe there is the potential for LQDA to add a possible objection into the FTC mix, after all they are left standing alone at the alter now with what looks to be an inferior product, at worst I would expect that UTHR might have to divest some of their stranglehold on the PAH market if it is deemed there is an anti-trust issue. I am expecting/suspect that FUD to come into play while the 30 day period is in effect. In the end however, UTHR married with the right partner and it should be a win-win for both parties going forward. Could it have been a better deal had the company been in a different position, absolutely, but the more important aspect is the overwhelming vote of confidence UTHR displayed in Technosphere with the additional research request. Enjoy your weekends I don’t understand any of this. In layman terms what are you saying?🧐 |
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Post by awesomo on Sept 7, 2018 19:19:04 GMT -5
Remember the term "the Bernanke Put" well that was to put a floor on the market and give investors the confidence to re-enter the markets and clearly gave a buy signal to the fund managers etc. The UTHR Put as I will refer to it is essentially the same idea regarding the buy side of this equity. IMO a "floor" has been established and solidified with Tuesday's announcement regarding the cash injection and potential cash inflows from the remaining milestones and royalties. Although I already have a fairly large core position, I purchased 20K (with trading partner so really 10K each) trading shares this morning at 1.71 which will be used to buy on any dips. I believe with the UTHR announcement that any dips will now be bought and the existing short shares will compete with new buyers looking to establish long positions. IMO this should be a buy the dip and sell the rip equity for a buy side bias going forward for trading shares only. If you are not trading any shares and have a core long position then you know what the longer term positives are for the company at this point. One caveat to the UTHR situation is that I believe there is the potential for LQDA to add a possible objection into the FTC mix, after all they are left standing alone at the alter now with what looks to be an inferior product, at worst I would expect that UTHR might have to divest some of their stranglehold on the PAH market if it is deemed there is an anti-trust issue. I am expecting/suspect that FUD to come into play while the 30 day period is in effect. In the end however, UTHR married with the right partner and it should be a win-win for both parties going forward. Could it have been a better deal had the company been in a different position, absolutely, but the more important aspect is the overwhelming vote of confidence UTHR displayed in Technosphere with the additional research request. Enjoy your weekends I don’t understand any of this. In layman terms what are you saying?🧐 Buy more MNKD at this price. |
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Post by mnholdem on Sept 7, 2018 21:40:43 GMT -5
I think the FTC would have a hard time making an anti-trust objection to a deal for a drug/delivery mechanism that has yet to go through Phase 3 trials. Plus, MNKD has no percentage of that market now, only a possibly superior delivery mechanism. I say "possibly" only because it hasn't earned approval as of yet. I also think you are right regarding the additional UTHR interest in other applications. Reading more about Rothblatt, it is clear that she is deeply interested in the subject of organ transplant and even organ manufacturing where there seems to be other possible applications for TI. I like the idea of the UTHR put and think it has real merit. It will be interesting to see just what trials are required for an “already approved drug delivery device” combined with an “already approved drug” ?? Anybody have any ideas on what might be required. 😎 Phase 1 had primary outcomes of safety and tolerability of varying doses. Phase 3 primary outcome will measure effectiveness and no manufacturing certification for the device will be required, since the Dreamboat has already been approved. Future drug-device combinations that involve the Cricket inhaler may require certification of the device but this Phase 3 (TreT/Imodulin) trial will be fairly straightforward and will likely take 4-6 months, IMO. |
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Post by matt on Sept 10, 2018 8:05:49 GMT -5
It will be interesting to see just what trials are required for an “already approved drug delivery device” combined with an “already approved drug” ?? Anybody have any ideas on what might be required. 😎 The easy answer is whatever FDA decides they need to show in order to demonstrate safety and efficacy, which is also the mandate under federal law. Usually when a drug is already approved the focus is on the bioequivalence of what has already been approved. We know that Afrezza is not a one-for-one dosing comparable to injectables, so UTHR will be required to show how much inhaled drug is equivalent to the injected formulation. Inhaled drugs, all inhaled drugs, have less precise dosing than injectables so FDA will look carefully at dosing. The narrower the therapeutic window on a drug the more testing FDA will require. Beyond that, this is a combination of a known carrier particle with a known drug so there should be minimal safety issues with the components themselves. However, recall that FDA asked for an never received a Phase IV trial to evaluate the safety of long-term use of Afrezza. FDA may ask for something similar from UTHR and, unlike MNKD, they have the money, staff, and patient numbers to conduct the study so FDA may be less lenient on this requirement. |
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Post by Deleted on Sept 10, 2018 8:32:36 GMT -5
I don't think there's a stronghold for UTHR on PAH Market. I was looking at VVUS and they have a Phase 3 Trial for PAH treatment. Apparently there are other companies in the PAH market. FTC approval should come by EOM and the $45M will be released so MNKD can meet their DF covenant.
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Post by spudspud on Sept 10, 2018 9:17:08 GMT -5
Does anyone else think Mike C is just savage enough to announce another UTHR-like deal this week?
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Post by boytroy88 on Sept 10, 2018 9:22:05 GMT -5
Does anyone else think Mike C is just savage enough to announce another UTHR-like deal this week? I hope so! |
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Post by joeypotsandpans on Sept 10, 2018 9:38:24 GMT -5
Just updating, we sold 200 sep 14 2 calls @ .21 about 10 min ago bringing cost basis down to 1.50, or locking in .50 on those trading shares if called away, remember these are outside our core long position |
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