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Post by boca1girl on Apr 8, 2019 9:49:03 GMT -5
Still waiting for any clarity on the DTC program and any other Afrezza partnerships that weren’t recently denied (Brazil, Tanner, lol). Did you get a chance to listen to this morning’s web cast? An inspection of the mfg line was performed and approved after answering a few questions for Brazil. Everything was complete and submitted for approval. There was no target approval date given. It was 1Q but we are probably at the mercy of the regulatory agency in Brazil. Mike also said the denial for expedited approval in India was expected but worth the exercise. And he said the small local trial will be conducted by Cipla.
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Post by sportsrancho on Apr 8, 2019 10:51:48 GMT -5
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Post by sportsrancho on Apr 8, 2019 10:52:15 GMT -5
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Post by hellodolly on Apr 8, 2019 11:03:51 GMT -5
This sums up everything, right here in one sentence for this new RHI Board Member, "By leveraging patented, proven drug delivery technologies, Receptor’s products have the potential to improve and expand the therapeutic utility of cannabinoid medicines.” In fact, that's the only thing highlighted! Pretty convincing what we have here with TI, or at least what others feel about this technology, as it emerges from the shadows.
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Post by tw12 on Apr 8, 2019 11:10:33 GMT -5
Thanks for posting, sports.
As MK points out and as Mike C's slides this morning showed, the lid is beginning to come off of our RLS relationship, at last; and it seems a wide and profitable horizon, not least beneficial as well to so many worldwide. And Casdin too adds incredible experience and respect to RLS.
So The Secret will soon be known, after three plus years of channeling Robert Frost's poem since that first announcement:
We dance round in a ring and suppose,
But the Secret sits in the middle and knows.
It's all good!
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Post by cjm18 on Apr 8, 2019 11:32:10 GMT -5
ceo of rls is Gregory Wesner since January. He helped mannkind with patents according to his description on the rls website.
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Post by mnholdem on Apr 8, 2019 11:34:23 GMT -5
Not really. Confidentiality is still enforced by Agreement for strategic purposes. It’s common. You were replying to shake who wrote: "Mike just talked a lot about rls and we havent heard a peep from rls themselves". So you think a confidentiality agreement could allow Mannkind to talk about RLS, but RLS has to keep quiet about itself? That would seem odd to me. If you listened to the website, Mike spoke to cannabis in general and applied it to global distribution via Canada. He did not specifically state that would be the route that Receptor Life Sciences would take with its line of future Technosphere drugs, but he certainly implied it.
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Post by Thundersnow on Apr 8, 2019 11:51:30 GMT -5
Did anyone catch Mike's comments that MNKD has tested kids down to 8 years old? Apparently there will not be a COHORT 3 and will go straight into a Phase 3 Trial which also means they can file in the EU and other countries. HUGE Development IMO.
I just asked a Pediatric Endo and he said the prime age for kids becoming Type 1 is 3-6 years old and teenage years so I'm wondering why MNKD will not do a cohort 3 unless the FDA is not requiring it? Which could be good news.
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Post by longliner on Apr 8, 2019 11:51:57 GMT -5
You were replying to shake who wrote: "Mike just talked a lot about rls and we havent heard a peep from rls themselves". So you think a confidentiality agreement could allow Mannkind to talk about RLS, but RLS has to keep quiet about itself? That would seem odd to me. If you listened to the website, Mike spoke to cannabis in general and applied it to global distribution via Canada. He did not specifically state that would be the route that Receptor Life Sciences would take with its line of future Technosphere drugs, but he certainly implied it. All systems go! Continuing to accumulate.
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Post by boca1girl on Apr 8, 2019 12:41:17 GMT -5
Did anyone catch Mike's comments that MNKD has tested kids down to 8 years old? Apparently there will not be a COHORT 3 and will go straight into a Phase 3 Trial which also means they can file in the EU and other countries. HUGE Development IMO. I just asked a Pediatric Endo and he said the prime age for kids becoming Type 1 is 3-6 years old and teenage years so I'm wondering why MNKD will not do a cohort 3 unless the FDA is not requiring it? Which could be good news. I listened but heard something a little different. I heard they were just about done with Cohort 2 but did not hear that they were cancelling Cohort 3. I’ll have to listen again. Update: at 20:00 mark he talked about pediatrics. He did not say anything about Cohort 3 but did say we could go into Phase 3 after finishing Cohort 2 and then mentioned that we can file for European approval.
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Post by sportsrancho on Apr 8, 2019 12:45:21 GMT -5
MK..Michael Kovacocy Michael Kovacocy 2m · Edited
MNKD ($1.79) - Now for the flip side of the coin...Can be bullish but strict on policy...It is my firm opinion that no matter what management is doing for the long term, they have been very, very sloppy with protecting and increasing the PPS. A lot of what has been done could have been done on better terms for the average common shareholder. Just today the CEO conveniently brushed aside any culpability for a horribly done December offering by merely stating that the ad campaign did not deliver as expected and they “will wait to see a few weeks”. Sorry, but that doesn’t cut it when you hosed shareholders in December because aside from expecting market weakness to raise money in “(did not happen) you told your shareholders that you had to launch a new big ad campaign ASAP and the financing was part and parcel of that. The buck must stop at the CEO’s desk. There is zero way management deserves any bonuses for 2018, and hell should freeze over before they see raises. I am fair and objective - with shareholders my #1 concern. VOTE AGAINST PROP 2, AND AGAINST A FEW OF THE LEGACY BAGGAGE Board Members. #MNKD
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Post by sportsrancho on Apr 8, 2019 12:48:49 GMT -5
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Post by mnkdfann on Apr 8, 2019 13:21:01 GMT -5
You were replying to shake who wrote: "Mike just talked a lot about rls and we havent heard a peep from rls themselves". So you think a confidentiality agreement could allow Mannkind to talk about RLS, but RLS has to keep quiet about itself? That would seem odd to me. If you listened to the website, Mike spoke to cannabis in general and applied it to global distribution via Canada. He did not specifically state that would be the route that Receptor Life Sciences would take with its line of future Technosphere drugs, but he certainly implied it. Thanks. I did not listen to the webcast. I relied on what people reported here, and I should have known better. LOL. (No offense intended to shake, or anyone else in particular.)
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Post by ktim on Apr 8, 2019 13:36:14 GMT -5
Interesting that it appears OTC CBD is brought into the picture, which was not part of the MNKD presented RLS story in previous presentations.
CBD vape pens are already available, but it also seems people choose oils or edibles more often. Wonder what they feel would be the selling point of TS based CBD. An indication requiring quick onset and clearance and precise dosing. There may be some uses that have those requirements, but I think that would be a relatively tiny bit of the entire market. I've tried CBD for insomnia, where the rapid pk would be counter productive.
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Post by Deleted on Apr 8, 2019 14:03:20 GMT -5
Did anyone catch Mike's comments that MNKD has tested kids down to 8 years old? Apparently there will not be a COHORT 3 and will go straight into a Phase 3 Trial which also means they can file in the EU and other countries. HUGE Development IMO. I just asked a Pediatric Endo and he said the prime age for kids becoming Type 1 is 3-6 years old and teenage years so I'm wondering why MNKD will not do a cohort 3 unless the FDA is not requiring it? Which could be good news. Around five or so years ago, the FDA asked Mannkind to test Afrezza in children as young as 4. Everyone knows how well Afrezza works and the PK / PD profile. Having a 4 year old go from multiple daily injections (MDI) to a simple and easy to use inhaled product that offers better outcomes just might have a small tad of appeal to children and their parents. There will come a day when fee for outcomes is the norm and fee for service is no more. When time in range becomes the measuring stick for fee for outcomes, which Rx products for people with diabetes will garner the greatest reimbursement? This fall, DexCom will have their production lines up and running for their new, very small and inexpensive CGM. Diameter is between a nickel and quarter and around twice as thick as the latter. It will send continuous glucose readings to a smartphone and from there, the possibilities are endless. What % of the patient population has a compliant A1c and what % of patients on a CGM have good time in range? This fall things get interesting. Will some of the big players making oral meds for diabetes want Afrezza so they can go toe to toe with Lilly, Novo and Sanofi?
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