|
Post by rtmd on Jul 11, 2019 22:18:35 GMT -5
Spencer told everybody what the name of the unnamed molecule was. Unfortunately I can’t remember the name. It has the same compound in it that Cialis does but would not be used in the same way. As far as Epi goes your throat doesn’t close up for 20 minutes, there’s plenty of time to inhale. Why would you need to carry a pen also? Those pens expire in 18 months, people have to pay $1200 every 18 months to carry them. And with the Epi inhaler you can do it at the first sign of something, doesn’t matter if you’re wrong or not it will not hurt you in the least. People are hesitant to take the shot because they’re not sure. Tadalafil Brand name: Cialis remember tada? Mike did say the undisclosed molecule had consumer demand. On goodrx, generic cialis sells for $25 for 30 tabs. Per the label, onset of action is within 30 minutes. I don't see where it would be all that profitable to develop an inhaled version.
|
|
|
Post by peppy on Jul 11, 2019 22:30:38 GMT -5
Tadalafil Brand name: Cialis remember tada? Mike did say the undisclosed molecule had consumer demand. On goodrx, generic cialis sells for $25 for 30 tabs. Per the label, onset of action is within 30 minutes. I don't see where it would be all that profitable to develop an inhaled version. what mg? Viagra selling for 4 bucks, 20 mg. The viagra pill was 100 mg. 4 x 5 = 20 dollars/100mg. Medication can be tricky. tricky dickey. the 30 min onset of action is on an empty stomach. Do me a favor. Eat a pizza. Take a Cialis. start the stop watch and report back. TIA.
|
|
|
Post by peppy on Jul 11, 2019 22:39:37 GMT -5
Very possible, I’ve just had a lot of personal experience with people that have had it happen..my ex-husband, a roommate, the wife of a friend. Of course statistically that’s not saying much it’s just my own experience. I think a bigger problem would be getting docs to prescribe it. How do you explain to a malpractice jury that you prescribed an inhaled drug to treat an ailment whose hallmarks are airway constriction and difficulty breathing? www.unither.com/products.htmlAdcirca (tadalafil) is a phosphodiesterase 5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH)(WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
|
|
|
Post by plytle on Jul 11, 2019 22:45:08 GMT -5
Very possible, I’ve just had a lot of personal experience with people that have had it happen..my ex-husband, a roommate, the wife of a friend. Of course statistically that’s not saying much it’s just my own experience. I think a bigger problem would be getting docs to prescribe it. How do you explain to a malpractice jury that you prescribed an inhaled drug to treat an ailment whose hallmarks are airway constriction and difficulty breathing? Hello. Ever heard of asthma? I have...and have had it for 47 years. It's pretty much a disease that is ALL ABOUT a person's inability to breathe. What happens when you have a severe attack and breathe? You take your inhaler. Come on.
|
|
|
Post by mnkdfann on Jul 11, 2019 23:36:29 GMT -5
I think a bigger problem would be getting docs to prescribe it. How do you explain to a malpractice jury that you prescribed an inhaled drug to treat an ailment whose hallmarks are airway constriction and difficulty breathing? Hello. Ever heard of asthma? I have...and have had it for 47 years. It's pretty much a disease that is ALL ABOUT a person's inability to breathe. What happens when you have a severe attack and breathe? You take your inhaler. Come on. Is there as effective an alternate rescue medication available for ashtma in this case? If there is no other good option, you have to use what is available.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 11, 2019 23:58:56 GMT -5
I'm curious as to why they threw in Epi in that PR. If the main goal of this expansion was primarily due to Trep-T then shouldn't they have just said it? Another PR with more questions than answers, I wish Mike & Co would just tear off the band-aid once and for all with some real clarity and transparency. Just those 3 extra words: "such as epinephrine". As an example of a dry powder formulation, it is one that most readers would be familiar with. They could have listed something more exotic, such as Treprostinil, but a lot of retail investor readers (especially those not currently invested in Mannkind, i.e. potential investors) may not be so familiar with that. Even some analysts, I suppose. Also, whether Mannkind has any real intention to do Epi or not, mentioning it still excites its devoted retail fan base. And, of course, it could signal that Mannkind is serious about doing Epi. I think it's fair to say, without knowing more, that the PR wasn't as clear as it could be. It raises unanswered questions. MNKD had discussions with the FDA about 2 years ago regarding EPI but they were discouraged to proceed with R&D. Lately discussions were reopened and MNKD received a more favorable response from them which caused MNKD to seriously look into high potency drugs. Not sure if TreT is classified as HP but EPI and possibly Cialis type molecule could be. A positive is that when MNKD gets a green light from a potential partner and/or FDA they will have their infrastructure already in place.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 12, 2019 0:06:40 GMT -5
I agree with mnkdfann , I would be weary just carrying a inhaler. Or what if I don’t inhale enough of the dose? I could see people carrying both but from a cost perspective isn’t really isn’t feasible. Insurance barely wants to cover the pen, no way they will cover both This is the deal. Most people know when an allergic reaction is approaching. Usually they have about 20 minutes from onset to full blown stop breathing unconsciousness. So it's that 20 minutes that MNKD's EPI HALE will fit with their CRICKET Device. Just imagine the cost savings. MNKD could charge $100 bucks vs $600 for an EPI Pen. If insurance is involved it could be as low as $50 to the patient. That's a HOMERUN for MNKD because the production cost will be minimal. HUGE MARGINS. And you will have less fear of patients JABBING a PEN into their thigh every time. I see huge market potential.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 12, 2019 0:09:36 GMT -5
Something here just doesn't seem right. If there were a deal then they would have announced the deal and then followed up with a PR stating the manufacturing expansion. To those who are excited about this, I get that you want to see expansion of Technosphere but based on this PR I would be wary, I would be very wary. The milestone payment for the 2H of the year for TreT is tied to the buildout of the manufacturing facility. This means that things are progressing the way they should and MNKD is on track to get the milestone payment. There is nothing to be wary about with respect to this announcement, other than your post. This is also the reason why Phase 3 has not started for TreT. MNKD had to complete their facility expansion because the FDA needs to inspect it. Expect TreT Phase 3 to start next month.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 12, 2019 0:16:28 GMT -5
Tadalafil Brand name: Cialis remember tada? Mike did say the undisclosed molecule had consumer demand. On goodrx, generic cialis sells for $25 for 30 tabs. Per the label, onset of action is within 30 minutes. I don't see where it would be all that profitable to develop an inhaled version. Are you kidding? I would rather inhale and have an erection within 60 seconds vs 30 Minutes. Talk about a mood killer. And MEN will pay a premium for a 60 sec HARDON. The only issue would be discreteness and noise.
|
|
|
Post by mnkdfann on Jul 12, 2019 1:00:17 GMT -5
I agree with mnkdfann , I would be weary just carrying a inhaler. Or what if I don’t inhale enough of the dose? I could see people carrying both but from a cost perspective isn’t really isn’t feasible. Insurance barely wants to cover the pen, no way they will cover both This is the deal. Most people know when an allergic reaction is approaching. Usually they have about 20 minutes from onset to full blown stop breathing unconsciousness. So it's that 20 minutes that MNKD's EPI HALE will fit with their CRICKET Device. Just imagine the cost savings. MNKD could charge $100 bucks vs $600 for an EPI Pen. If insurance is involved it could be as low as $50 to the patient. That's a HOMERUN for MNKD because the production cost will be minimal. HUGE MARGINS. And you will have less fear of patients JABBING a PEN into their thigh every time. I see huge market potential. Yes, and I remember when people argued that fear of needles would lead to fast and massive acceptance of Afrezza. Time alone will tell if Epi is coming to Mannkind, and whether it proves to be a game changer.
|
|
|
Post by anderson on Jul 12, 2019 5:50:42 GMT -5
As far as Epi goes your throat doesn’t close up for 20 minutes, there’s plenty of time to inhale. Why would you need to carry a pen also? Those pens expire in 18 months, people have to pay $1200 every 18 months to carry them. And with the Epi inhaler you can do it at the first sign of something, doesn’t matter if you’re wrong or not it will not hurt you in the least. People are hesitant to take the shot because they’re not sure. According to various expert opinions I've seen, like those at the Mayo clinic, wheezing and gasping can start within seconds to a few minutes for some people. Your throat may not be closed, but it may already be too hard for you to inhale (properly and successfully) a powder medication at that point. Heck, we all know that some people with unrestricted throats and perfect breathing have had difficulty inhaling Afrezza properly for their first attempts, and we've all heard of people who stopped using Afrezza because it didn't work (likely because they did not inhale properly). Yeah like those asthma attacks that people use to use Primatene Mist? Maybe if they made a powered inhaler that helped you inhale. Also Primatene Mist is epinephrine, so who holds the rights to Primatene? Answer Amphastar Pharmaceuticals. So maybe it isn't an Epi pen replacement....
|
|
|
Post by hellodolly on Jul 12, 2019 5:55:30 GMT -5
Totally non medical guess. Usually if someone is unconscious it is because they were reluctant to jab themselves with an epi pen. If you can inhale it you won't wait. I'm with you on this, totally irrelevant. This is the same kind of argument you heard people shouting when they began pushing a national agenda of having driver's wear their seatbelts. The ridiculous come back was, "What if I roll into a canal and become unconscious, how do I get out?" LOL.
Another related example having to do with CPR. If they can breathe, even gasp...they are breathing. Don't rescue breath for them...only when they stop but, even now, that's not the recommendation anymore. Chest compressions only.
|
|
|
Post by rtmd on Jul 12, 2019 8:02:21 GMT -5
On goodrx, generic cialis sells for $25 for 30 tabs. Per the label, onset of action is within 30 minutes. I don't see where it would be all that profitable to develop an inhaled version. Are you kidding? I would rather inhale and have an erection within 60 seconds vs 30 Minutes. Talk about a mood killer. And MEN will pay a premium for a 60 sec HARDON. The only issue would be discreteness and noise. Why would you need 60 seconds? Cialis effect lasts up to 36 hours. You could take one Friday evening before going out and be good to go through Sunday morning.
|
|
|
Post by rtmd on Jul 12, 2019 8:14:40 GMT -5
I agree with mnkdfann , I would be weary just carrying a inhaler. Or what if I don’t inhale enough of the dose? I could see people carrying both but from a cost perspective isn’t really isn’t feasible. Insurance barely wants to cover the pen, no way they will cover both This is the deal. Most people know when an allergic reaction is approaching. Usually they have about 20 minutes from onset to full blown stop breathing unconsciousness. So it's that 20 minutes that MNKD's EPI HALE will fit with their CRICKET Device. Just imagine the cost savings. MNKD could charge $100 bucks vs $600 for an EPI Pen. If insurance is involved it could be as low as $50 to the patient. That's a HOMERUN for MNKD because the production cost will be minimal. HUGE MARGINS. And you will have less fear of patients JABBING a PEN into their thigh every time. I see huge market potential. No, the deal is that anaphylaxis is a life threatening emergency that can develop over minutes and if you were doc, would you prescribe it knowing that its hallmark traits are difficulty breathing and airway constriction? I certainly wouldn't want to risk facing a malpractice suit if someone died. For that matter, would the FDA even consider it as a possible treatment for anaphylaxis? Someone else mentioned it as a treatment for asthma, but, as pointed out by elsewhere, Amphastar already has Primatene mist and have done nothing more to gain approval. One reason, as I vaguely recall, was that plain epinephrine is not a good drug for asthma since it is short acting and produces a rebound phenomenon similar to nasal sprays so the patient has to use more and more of it each time to relieve symptoms. Overall, I think I would discourage spending money on epinephrine.
|
|
|
Post by Clement on Jul 12, 2019 8:55:13 GMT -5
"High Potency A growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HP APIs) – molecules that are proven to be effective at much smaller dosage levels than traditional APIs. The HP APIs are classified based on their toxicity, pharmacological potency and occupational exposure limits (OELs). These APIs are frequently characterized by complex structures requiring multi-step processes or semi-synthesis, often involving more than 10 steps. High-containment manufacturing requires specialized approaches in facility design, equipment selection and manufacturing processes to achieve desired levels of containment, minimize operator exposure, and ensure worker protection and safety." www.tapi.com/services/api-expertise/high_potency/
|
|