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Post by mannmade on Jan 4, 2019 13:37:35 GMT -5
People can leverage the Vdex white paper by sharing with all their friends on social media and their own doctors etc... create a grassroots media campaign to support their efforts. Anyone with media connections would be a huge plus! Am sure they would be open to interviews...
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Post by mannmade on Jan 4, 2019 14:34:28 GMT -5
Mike also mentioned that there would be a new direct way to buy afrezza without insurance. Could this be part of the One Drop partnership previously referenced last year? Or is it part of new card he mentioned?
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Good CC
Jan 4, 2019 15:56:02 GMT -5
Post by mytakeonit on Jan 4, 2019 15:56:02 GMT -5
I slept thru the CC due to the six hour time difference, but wanted to thank you all for providing a really good synopsis for me to get up to speed on what transpired! I guess the only question I have is, was there any discussion about authorizing more shares in the call? I'm assume not, since I saw no discussion regarding that. Aloha. Actually, the time difference is 5 hours during the winter months. So, I assume you turned on too early and turned it off before it started.
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Good CC
Jan 4, 2019 17:01:52 GMT -5
via mobile
Post by mango on Jan 4, 2019 17:01:52 GMT -5
I wanted to get my thoughts down on electronic paper after the CC. I didn’t love or hate the CC. It is past time though that Mannkind executes and delivers instead of offering promises and potential for future glory. 1. Financials With the latest raise, Mike said that we are funded through mid-2020. He said that we have 70 million in cash at beginning of 2019 and he expects another $37.5 million in TrepT milestones in the next 18 months. I’m assuming he means that plus any revenues from Afrezza will get us through mid-2020. He didn’t ask for more shares being authorized and didn’t even mention that at all in his scripted comments or in answering the questions. He did mention about getting shares back over the next year if another capital raise is needed down the line. He lost me a bit here in terms of how many shares we are getting back. 2. Technosphere Molecules He mentioned moving forward on 7 molecules and then identified four of them (migraine, chemo, cystic fibrosis and undisclosed). Based on his later comments, I would assume RLS is #5. What are the other two? 3. Expansion of TV Campaign and Focusing on 30 States Mike mentioned that we will vastly expand our TV campaign starting in the middle of the month and that we are exiting 14 states to focus on 30 states where there is the most potential for Afrezza scripts and where over 90% of Afrezza scripts currently derive. I think the idea with this focus is to show that Afrezza is commercially viable if there are adequate resources put into it. By focusing on a reduced number of territories, I believe Mannkind is trying to show this in hopes of finding a future partner for Afrezza with deeper pockets than Mannkind to promote Afrezza. 4. International Expansion It sounds like Brazil is close but not across the finish line. Mike alluded to the holidays as a reason for the delay. He stated that he expects to file in Canada in the first half of the year and Europe later in 2019. He mentioned India at what point but did not provide an update. Feel free to add to the above or correct me if I’m wrong on anything. "And we also we talked about RLS as one of the seven pipeline compounds because they just raised $30 million." Yeah, RLS is number 5. Curious also what 6 & 7 could be...
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Good CC
Jan 4, 2019 17:03:25 GMT -5
via mobile
Post by mango on Jan 4, 2019 17:03:25 GMT -5
I wanted to get my thoughts down on electronic paper after the CC. I didn’t love or hate the CC. It is past time though that Mannkind executes and delivers instead of offering promises and potential for future glory. 1. Financials With the latest raise, Mike said that we are funded through mid-2020. He said that we have 70 million in cash at beginning of 2019 and he expects another $37.5 million in TrepT milestones in the next 18 months. I’m assuming he means that plus any revenues from Afrezza will get us through mid-2020. He didn’t ask for more shares being authorized and didn’t even mention that at all in his scripted comments or in answering the questions. He did mention about getting shares back over the next year if another capital raise is needed down the line. He lost me a bit here in terms of how many shares we are getting back. 2. Technosphere Molecules He mentioned moving forward on 7 molecules and then identified four of them (migraine, chemo, cystic fibrosis and undisclosed). Based on his later comments, I would assume RLS is #5. What are the other two? 3. Expansion of TV Campaign and Focusing on 30 States Mike mentioned that we will vastly expand our TV campaign starting in the middle of the month and that we are exiting 14 states to focus on 30 states where there is the most potential for Afrezza scripts and where over 90% of Afrezza scripts currently derive. I think the idea with this focus is to show that Afrezza is commercially viable if there are adequate resources put into it. By focusing on a reduced number of territories, I believe Mannkind is trying to show this in hopes of finding a future partner for Afrezza with deeper pockets than Mannkind to promote Afrezza. 4. International Expansion It sounds like Brazil is close but not across the finish line. Mike alluded to the holidays as a reason for the delay. He stated that he expects to file in Canada in the first half of the year and Europe later in 2019. He mentioned India at what point but did not provide an update. Feel free to add to the above or correct me if I’m wrong on anything. "And we also we talked about RLS as one of the seven pipeline compounds because they just raised $30 million." Yeah, RLS is number 5. Curious also what 6 & 7 could be...Oh ok just looked back and see this has already been solved. 3 between UT & RLS 4 triptan, 5HT3, Trobramycin, Undisclosed
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Post by matt on Jan 4, 2019 17:09:14 GMT -5
Mike also mentioned that there would be a new direct way to buy afrezza without insurance. Could this be part of the One Drop partnership previously referenced last year? Or is it part of new card he mentioned? It is more likely a relationship with a mail order pharmacy, which is a regulatory requirement regardless if it includes OneDrop or any new payment options. Since only licensed pharmacists can accept prescriptions from physicians and dispense drugs, there must be one somewhere in the chain of commerce. If MNKD is having trouble getting traction with the PBM owned pharmacies, like CVS/Caremark, it makes perfect sense to go to a second tier mail order network as they can easily handle the volume.
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Good CC
Jan 4, 2019 17:15:08 GMT -5
Post by travis1953 on Jan 4, 2019 17:15:08 GMT -5
The CEO mentioned actually selling -- as I understood him -- directly from Mannkind to consumers. It seems like there would be regulatory hurdles. Also, wouldn't distributors object to by passing them?
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Good CC
Jan 4, 2019 17:18:09 GMT -5
Post by peppy on Jan 4, 2019 17:18:09 GMT -5
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Good CC
Jan 4, 2019 17:43:32 GMT -5
Post by hellodolly on Jan 4, 2019 17:43:32 GMT -5
The CEO mentioned actually selling -- as I understood him -- directly from Mannkind to consumers. It seems like there would be regulatory hurdles. Also, wouldn't distributors object to by passing them? I would think that this plays into Mike's wheelhouse as a prior Pharmacist. I'm sure he's got his fingers in the middle of the current laws, practices and methods that are allowed by Manufacturers. Let's hope this becomes something new that can help those who are having difficulty with their pharmacies and/or even the insurance. Mike may be able to do something with them, as well through this process. Don't know the answers, but tossing it up here to get some feedback and more answers for you.
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Post by ltta on Jan 4, 2019 17:45:24 GMT -5
I agree and you could likely address your notes w simply revising the narrative for the script voice over. The real issue may be the time and cost of getting fda approval for revised script. From the FDA website:
Does the FDA review and approve all advertisements for drugs before their release?
No. In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used. We see many ads at about the same time the public sees them. Many drug companies voluntarily seek advice from us before they release TV ads. However, if we believe that an ad violates the law, we send a letter to the drug company asking that the ads be stopped right away.
Does the FDA approve ads for prescription drugs before they are seen by the public?
No, generally we do not. Except in unusual instances, we cannot require drug companies to submit ads for approval before they are used. Drug companies must only submit their ads to us when they first appear in public. This rule is the same whether the ads are aimed toward healthcare providers or consumers. This means that the public may see ads that violate the law before we can stop the ad from appearing or seek corrections to the ad. Consumers should know that they may not necessarily be able to tell whether any specific DTC ad includes false or misleading information.
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Good CC
Jan 4, 2019 17:50:22 GMT -5
Post by Clement on Jan 4, 2019 17:50:22 GMT -5
I agree and you could likely address your notes w simply revising the narrative for the script voice over. The real issue may be the time and cost of getting fda approval for revised script. From the FDA website:
Does the FDA review and approve all advertisements for drugs before their release?
No. In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used. We see many ads at about the same time the public sees them. Many drug companies voluntarily seek advice from us before they release TV ads. However, if we believe that an ad violates the law, we send a letter to the drug company asking that the ads be stopped right away.
So, not required. But maybe it's a good idea to get FDA to sign off on an ad before full production and release .... to avoid wasting time and money.
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Good CC
Jan 4, 2019 17:51:23 GMT -5
Post by lennymnkd on Jan 4, 2019 17:51:23 GMT -5
If it is one drop , I belive it’s thru Amazon ...
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Post by nylefty on Jan 4, 2019 17:53:12 GMT -5
A quick Google search found this: www.ncbi.nlm.nih.gov/pmc/articles/PMC5998458/Direct-to-consumer (DTC) medication sales have quietly emerged as a novel way for consumers to receive prescription drugs. Recently, several medications have become readily available from their manufacturers and are sold directly to patients via prescriptions that are sent to drug companies rather than traditional pharmacies, bypassing wholesalers. Company-sponsored medication assistance programs have offered branded prescription medications directly to patients in the United States with limited incomes for years; however, this practice involves the actual sale of prescription product to a patient by a pharmaceutical company.
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Post by nylefty on Jan 4, 2019 17:59:33 GMT -5
From the FDA website:
Does the FDA review and approve all advertisements for drugs before their release?
No. In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used. We see many ads at about the same time the public sees them. Many drug companies voluntarily seek advice from us before they release TV ads. However, if we believe that an ad violates the law, we send a letter to the drug company asking that the ads be stopped right away.
So, not required. But maybe it's a good idea to get FDA to sign off on an ad before full production and release .... to avoid wasting time and money. Mike has said that the FDA rejected the first version of the current ad because it seemed to encourage diabetics to eat pizza. mnkd.proboards.com/post/162441/thread
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Post by wgreystone on Jan 4, 2019 18:03:58 GMT -5
It's really a good conference call. Plan to add a little more shares next Monday if SP is still 20% below the offering price.
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