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Post by spudspud on Sept 10, 2018 9:39:57 GMT -5
Just updating, we sold 200 sep 14 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  selling at the money puts a month out looks pretty tasty too |
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Post by peppy on Sept 10, 2018 9:41:36 GMT -5
Just updating, we sold 200 sep 14 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 selling at the money puts a month out looks pretty tasty too I think you should do that spud spud. |
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Post by nylefty on Sept 10, 2018 12:21:42 GMT -5
Does anyone else think Mike C is just savage enough to announce another UTHR-like deal this week? sav·age ˈsavij adjective 1. (of an animal or force of nature) fierce, violent, and uncontrolled. "tales of a savage beast" synonyms: ferocious, fierce sav·vy ˈsavē adjective 1. shrewd and knowledgeable; having common sense and good judgment. synonyms: shrewd, astute, sharp-witted, sharp, acute, adroit, intelligent, clever, canny, perceptive, perspicacious, sagacious, sage, wise |
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Post by spudspud on Sept 10, 2018 14:01:06 GMT -5
Does anyone else think Mike C is just savage enough to announce another UTHR-like deal this week? sav·age ˈsavij adjective 1. (of an animal or force of nature) fierce, violent, and uncontrolled. "tales of a savage beast" synonyms: ferocious, fierce sav·vy ˈsavē adjective 1. shrewd and knowledgeable; having common sense and good judgment. synonyms: shrewd, astute, sharp-witted, sharp, acute, adroit, intelligent, clever, canny, perceptive, perspicacious, sagacious, sage, wise Savvy may work better, but I like that idea of savagely goring the shorts! |
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Post by rockstarrick on Sept 10, 2018 14:04:52 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. Thanks matt, I appreciate the response. It is strange that mnkd didn’t follow thru with the p4 trial, but what is even more confusing is the fact that the fda actually dropped a safety follow up requirement for some reason ?? I’m not sure what was dropped, or why it was dropped. I just remember something about this a while back. Also, I think the number of adverse reactions to Afrezza has significantly dropped in 2018, I think I read an article that was shared on ST about this. It will be exciting to see MNKD and UTHR move forward with TrepT and the mysterious second molecule that is currently in the r&d stage. ts a good time to be a mnkd long Investor. ✌🏻😎 |
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Post by spudspud on Sept 10, 2018 14:23:53 GMT -5
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Post by spudspud on Sept 10, 2018 14:32:36 GMT -5
Sounds like the second drug is basically inhaled Cialis ..... lol! how much “off label” use we going to see on that bad boy, by some bad boys?
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Post by matt on Sept 10, 2018 15:18:39 GMT -5
Thanks matt, I appreciate the response. It is strange that mnkd didn’t follow thru with the p4 trial, but what is even more confusing is the fact that the fda actually dropped a safety follow up requirement for some reason ?? I’m not sure what was dropped, or why it was dropped. I just remember something about this a while back. Also, I think the number of adverse reactions to Afrezza has significantly dropped in 2018, I think I read an article that was shared on ST about this. It will be exciting to see MNKD and UTHR move forward with TrepT and the mysterious second molecule that is currently in the r&d stage. ts a good time to be a mnkd long Investor. ✌🏻😎 I don't think the FDA has dropped the requirement; they simply have not enforced the terms of the approval. FDA wanted follow-up data on a large number of regular users, 8000 subjects as I recall, but Afrezza does not have that many users so they are not in a position to do the study. If FDA wanted to play hard ball, they could simply revoke the marketing approval until the study was done but they rarely do that for a small company or when circumstances make it nearly impossible to do the Phase IV study. It is sort of a chicken and egg problem; if Mannkind has 8,000 regular users then they would have enough money to do the Phase IV, but without many thousands of recurring users they are short on cash. Which is my point about UTHR being a larger company with more money, resources, and an established patient base. FDA may have to cut Mannkind some slack on the Phase IV requirement, but they may not do the same for others. At some point somebody is going to have to come up with the long-term data and that is a good thing if it helps avoid a black box warning on the label for other drugs (black boxes are never good for sales). |
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Post by babaoriley on Sept 10, 2018 17:42:25 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 From hanging on by a thread to an anti-trust target? Hmmm, I don't see that, Joey! But good of you to bring it up, cuz who knows who the shorts may have in their deep pockets at the FTC! |
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Post by goyocafe on Sept 10, 2018 18:02:49 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 From hanging on by a thread to an anti-trust target? Hmmm, I don't see that, Joey! But good of you to bring it up, cuz who knows who the shorts may have in their deep pockets at the FTC! Can't imagine, but we'd be tasked with deciding whether MNKD was the Rodney Dangerfield of biotech or the Achilles heal of big pharma. No one would be able to do a deal with MNKD since any deal would bankrupt the competiion, but as it stands, MNKD goes bankrupt without a deal. It could only happen to Mannkind. |
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Post by mnkdfann on Sept 10, 2018 18:04:18 GMT -5
Thanks matt, I appreciate the response. It is strange that mnkd didn’t follow thru with the p4 trial, but what is even more confusing is the fact that the fda actually dropped a safety follow up requirement for some reason ?? I’m not sure what was dropped, or why it was dropped. I just remember something about this a while back. Also, I think the number of adverse reactions to Afrezza has significantly dropped in 2018, I think I read an article that was shared on ST about this. It will be exciting to see MNKD and UTHR move forward with TrepT and the mysterious second molecule that is currently in the r&d stage. ts a good time to be a mnkd long Investor. ✌🏻😎 I don't think the FDA has dropped the requirement; they simply have not enforced the terms of the approval. FDA wanted follow-up data on a large number of regular users, 8000 subjects as I recall, but Afrezza does not have that many users so they are not in a position to do the study. If FDA wanted to play hard ball, they could simply revoke the marketing approval until the study was done but they rarely do that for a small company or when circumstances make it nearly impossible to do the Phase IV study. It is sort of a chicken and egg problem; if Mannkind has 8,000 regular users then they would have enough money to do the Phase IV, but without many thousands of recurring users they are short on cash. Possibly the FDA Elimination of the REMS requirement is what he (rockstarrick) was thinking of? mnkd.proboards.com/thread/9897/fda-elimination-rems-requirement |
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Post by peppy on Sept 10, 2018 18:06:07 GMT -5
Sounds like the second drug is basically inhaled Cialis ..... lol! how much “off label” use we going to see on that bad boy, by some bad boys? spud spud, allow me to respond, regarding Cialis and UTHR, allow me to tell you, that you are the last to know. Covered in another thread. You caught my attention with your genius put statement. Ha ha, you can call them bad boys, the men that need Cialis have a vascular and perhaps prostate problem or they are OLD and have both problems. So no bad boy carp-oli here. mnkd.proboards.com/thread/10423/united-therapeutics-mannkind-announce-collaboration?page=1 |
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Post by goyocafe on Sept 10, 2018 18:09:09 GMT -5
Sounds like the second drug is basically inhaled Cialis ..... lol! how much “off label” use we going to see on that bad boy, by some bad boys? spud spud, allow me to respond, regarding Cialis and UTHR, allow me to tell you, that you are the last to know. Covered in another thread. You caught my attention with your genius put statement. Ha ha, you can call them bad boys, the men that need Cialis have a vascular and perhaps prostate problem or they are OLD and have both problems. So no bad boy carp-oli here. I dunno. Popeye ate his spinach, and look what that did for him.  |
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Post by peppy on Sept 10, 2018 18:10:49 GMT -5
spud spud, allow me to respond, regarding Cialis and UTHR, allow me to tell you, that you are the last to know. Covered in another thread. You caught my attention with your genius put statement. Ha ha, you can call them bad boys, the men that need Cialis have a vascular and perhaps prostate problem or they are OLD and have both problems. So no bad boy carp-oli here. I dunno. Popeye ate his spinach, and look what that did for him. spinach.... Popeye took care of himself. No fat in spinach to clog up his vascular. you know I like you goyocafe. |
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Post by mango on Sept 10, 2018 18:11:49 GMT -5
Thanks matt, I appreciate the response. It is strange that mnkd didn’t follow thru with the p4 trial, but what is even more confusing is the fact that the fda actually dropped a safety follow up requirement for some reason ?? I’m not sure what was dropped, or why it was dropped. I just remember something about this a while back. Also, I think the number of adverse reactions to Afrezza has significantly dropped in 2018, I think I read an article that was shared on ST about this. It will be exciting to see MNKD and UTHR move forward with TrepT and the mysterious second molecule that is currently in the r&d stage. ts a good time to be a mnkd long Investor. ✌🏻😎 I don't think the FDA has dropped the requirement; they simply have not enforced the terms of the approval. FDA wanted follow-up data on a large number of regular users, 8000 subjects as I recall, but Afrezza does not have that many users so they are not in a position to do the study. If FDA wanted to play hard ball, they could simply revoke the marketing approval until the study was done but they rarely do that for a small company or when circumstances make it nearly impossible to do the Phase IV study. It is sort of a chicken and egg problem; if Mannkind has 8,000 regular users then they would have enough money to do the Phase IV, but without many thousands of recurring users they are short on cash. Which is my point about UTHR being a larger company with more money, resources, and an established patient base. FDA may have to cut Mannkind some slack on the Phase IV requirement, but they may not do the same for others. At some point somebody is going to have to come up with the long-term data and that is a good thing if it helps avoid a black box warning on the label for other drugs (black boxes are never good for sales). FDA works with the Insulin Cartel so of course they understand. |
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