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Post by brotherm1 on Jan 29, 2020 20:30:49 GMT -5
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Post by bioexec25 on Jan 29, 2020 20:31:23 GMT -5
Hooper and board members, et al, often contribute as much of more with their vast industry network of colleagues, FDA, vendors and payers. This is magnified with highly successful and active executives like Tony. I would reference the rolodex in a truck joke, but hey it's a digital world. :-)
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Post by mytakeonit on Jan 29, 2020 20:47:14 GMT -5
I'm going to throw my take on it and say that he's going to lead MNKD into expanding into Australia. It sounds like his wheel house and he states at around the 1:12 mark, in response to a question about his highlights in Australia, is that the Australians' "...ability to drive business and get to patients is better than I've ever seen before." Mike knows Hoop and it may in fact fit into their playbook. Hey ... quit throwing me around. But finally, someone get's it. MNKD is going international !!!
But, that's mytakeonit
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Post by letitride on Jan 29, 2020 20:56:04 GMT -5
You know what they say what comes around goes around, international it is. US a little slow on the uptake but it will come around.
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Post by ktim on Jan 29, 2020 21:02:55 GMT -5
No, and management listed countries that they planned to submit themselves (rather than partner), and I don't believe Australia was one of them. Perhaps Hooper will help find a partner. But best case sales there would still be years away. |
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Post by mytakeonit on Jan 30, 2020 2:07:38 GMT -5
You just said that the cop is wrong? OH NO !!! Ha! Okay ... so yes ... Brazil will be first.  Who is next? Beats me. I didn't bring my list with me. All I know is that U.S. will be last. Too bad ... so sad. But, that's mytakeonit |
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Post by mnholdem on Jan 30, 2020 13:57:28 GMT -5
No, and management listed countries that they planned to submit themselves (rather than partner), and I don't believe Australia was one of them. Perhaps Hooper will help find a partner. But best case sales there would still be years away. CEO Castagna stated that MannKind partnered with AMSL Diabetes "t o accelerate patients’ access to Afrezza in Australia." (May-2019) "Under the terms of the agreement, AMSL Diabetes will be responsible for obtaining regulatory and reimbursement approvals to distribute Afrezza in Australia. AMSL Diabetes will also be responsible for sales, marketing, and customer support and distribution activities. MannKind will retain responsibility for supply and manufacturing of Afrezza."Responsibility for obtaining regulatory approvals has been assign to Cipla (for India), Biomm S.A. (for Brazil) and AMSL Diabetes (for Australia).  |
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Post by ktim on Jan 30, 2020 14:57:03 GMT -5
No, and management listed countries that they planned to submit themselves (rather than partner), and I don't believe Australia was one of them. Perhaps Hooper will help find a partner. But best case sales there would still be years away. CEO Castagna stated that MannKind partnered with AMSL Diabetes "t o accelerate patients’ access to Afrezza in Australia." (May-2019) "Under the terms of the agreement, AMSL Diabetes will be responsible for obtaining regulatory and reimbursement approvals to distribute Afrezza in Australia. AMSL Diabetes will also be responsible for sales, marketing, and customer support and distribution activities. MannKind will retain responsibility for supply and manufacturing of Afrezza."Responsibility for obtaining regulatory approvals has been assign to Cipla (for India), Biomm S.A. (for Brazil) and AMSL Diabetes (for Australia). Yikes, my memory is going. Thanks for the correction. I usually look stuff up before posting to double check... that was a fail on my part in this case. |
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Post by matt on Jan 30, 2020 15:18:27 GMT -5
How long before approval. I know MC said it takes 1-2 years after applying in foreign countries. If the company has a complete file, it doesn't take that long to get approval. Most countries in the world use the CTD (common technical document) which has all the basic scientific data in a standardized format so that pharma companies don't have to reinvent the wheel for every new country, and some countries won't even accept a filing that does not use the CTD format (US and EU included). Adding any required nationalization sections (like translations of the package insert) are a fairly minor part of the process. Once a file is submitted, approval comes quickly if the file is complete and there are no unanswered questions about the drug. In the US, the FDA has a maximum of 270 days to review and approve a file, in the EU it is 210 days for the EMA to review with a further 60 day period for "official" approval by the European Parliament. There are few places that matter with approval times that exceed a year. The key is the company having a complete file. If the clinical trial work was sloppy or an important matter was not given sufficient attention during the testing process, the regulatory authority will reject the file until that work has been done satisfactorily. Rectifying file deficiencies can add anywhere from a few months to five years to a drug approval. |
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Post by hellodolly on Jan 30, 2020 16:36:38 GMT -5
How long before approval. I know MC said it takes 1-2 years after applying in foreign countries. If the company has a complete file, it doesn't take that long to get approval. Most countries in the world use the CTD (common technical document) which has all the basic scientific data in a standardized format so that pharma companies don't have to reinvent the wheel for every new country, and some countries won't even accept a filing that does not use the CTD format (US and EU included). Adding any required nationalization sections (like translations of the package insert) are a fairly minor part of the process. Once a file is submitted, approval comes quickly if the file is complete and there are no unanswered questions about the drug. In the US, the FDA has a maximum of 270 days to review and approve a file, in the EU it is 210 days for the EMA to review with a further 60 day period for "official" approval by the European Parliament. There are few places that matter with approval times that exceed a year. The key is the company having a complete file. If the clinical trial work was sloppy or an important matter was not given sufficient attention during the testing process, the regulatory authority will reject the file until that work has been done satisfactorily. Rectifying file deficiencies can add anywhere from a few months to five years to a drug approval. Helps with Hoop already having a background in the Australian regulatory process, his points of contact and wealth of knowledge he can use to submit the complete file, too. The dots may have been nearly connected on this one. |
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Post by ktim on Jan 30, 2020 19:45:35 GMT -5
If the company has a complete file, it doesn't take that long to get approval. Most countries in the world use the CTD (common technical document) which has all the basic scientific data in a standardized format so that pharma companies don't have to reinvent the wheel for every new country, and some countries won't even accept a filing that does not use the CTD format (US and EU included). Adding any required nationalization sections (like translations of the package insert) are a fairly minor part of the process. Once a file is submitted, approval comes quickly if the file is complete and there are no unanswered questions about the drug. In the US, the FDA has a maximum of 270 days to review and approve a file, in the EU it is 210 days for the EMA to review with a further 60 day period for "official" approval by the European Parliament. There are few places that matter with approval times that exceed a year. The key is the company having a complete file. If the clinical trial work was sloppy or an important matter was not given sufficient attention during the testing process, the regulatory authority will reject the file until that work has been done satisfactorily. Rectifying file deficiencies can add anywhere from a few months to five years to a drug approval. Helps with Hoop already having a background in the Australian regulatory process, his points of contact and wealth of knowledge he can use to submit the complete file, too. The dots may have been nearly connected on this one. Given that it is explicitly AMSL's responsibility for regulatory approval in Australia, I don't think a MNKD BoD member is going to be checking their work. Though I also assume if the trials done in US meet their regulator's criteria there would be no reason to suspect AMSL would not competently file the application. |
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Post by brotherm1 on Jan 30, 2020 20:36:01 GMT -5
I would hope at least someone from MNKD is holding hands with AMSL and ascertaining it’s all done properly and efficiently.
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Post by ktim on Jan 30, 2020 21:13:05 GMT -5
I would hope at least someone from MNKD is holding hands with AMSL and ascertaining it’s all done properly and efficiently. I have some semi relevant business experience. I was COO of a company that made a product that required a lot of regulatory approvals. We handled submitting all of that for US. Sometime later we had opportunity to sell to the Australian military through a partner located there, and in our agreements they were responsible for all approvals there. Some of the documents we used in US approval got used directly as is. In cases where additional or somewhat modified information was needed, they were the ones that determined what was needed. Anything that they prepared would be sent to us for review to make sure the way they presented details/data was technically accurate... but unless they had specific questions regarding interpretation of some Australian regulatory requirement, they were the ones responsible for making sure the submissions were done properly. There were actually many partners in many countries that operated this same way, just by chance one was Australia. Is that guaranteed to be the way this occurs... of course not. But, the wording of the announced relationship with AMSL would imply that is what would happen. It could have said that MNKD would handle regulatory submission and AMSL was on the hook to pay for it. The agreement implies that AMSL has the expertise to lead a submission in Australia. I'd certainly expect they get full and timely support from MNKD (and fortunately some overlap of normal work hours for phone calls). |
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Post by brotherm1 on Jan 30, 2020 21:25:44 GMT -5
Waht? “The agreement implies that AMSL has the expertise to lead a submission in Australia.“. What the heck are you saying? MNKD should not supervise an agreement?
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Post by ktim on Jan 30, 2020 21:52:51 GMT -5
Waht? “The agreement implies that AMSL has the expertise to lead a submission in Australia.“. What the heck are you saying? MNKD should not supervise an agreement? Don't think that is a valid interpretation of what I said. You seem to be accusing me of not doing my job when I was overseeing our international contracts  But perhaps here's another perspective. If Tony Hooper is somehow going to be a crucial aspect of executing that agreement... then something obviously went wrong, as they should not have selected a partner and structured the responsibilities the way they did if a high level person with specific Australian expertise is now seen as crucial in the submission process. I really doubt Tony Hooper will be overseeing it. That would be very odd. With or without Tony I'm sure they had all the bases covered since this deal has been in place for quite some time. Hopefully they are already nearing point of submittal. |
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Who is next? Beats me. I didn't bring my list with me. All I know is that U.S. will be last. Too bad ... so sad.
