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Coronavirus disease 2019 (COVID-19)

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Re: Coronavirus disease 2019 (COVID-19)

Postby FCBayernMunchen » Wed Jun 10, 2020 7:05 pm

RedQueen wrote:
ramsej84 wrote:
RedQueen wrote:Learned in yesterdays Drosten Podcast that pharma companies are working on re-shaping Remdesivir into an inhalative medication, which could be given to patients in the very early stages when they're just starting to develop symptoms. Remdesivir according to Drosten is actually a drug that should be given in early stages, when the virus hasn't yet attacked other organs or caused overshooting immune reactions or other problems, because it's specifically designed to inhibit virus replication. By inhaling it, it could directly affect respiratory organs, without having to pass through digestive tract and the blood stream. If successful, this could prevent a lot of severe cases and deaths.

There's been a lot of hopeful news lately, to the point where science journalists in Germany are already arguing there's a chance we could eliminate the virus completely. Yesterday our health minister Spahn said in a presser "we want to nip the virus in the bud", which seems to indicate another change of strategy (from "we have to prevent a collapse of our health system", to "we want to control local outbreaks", to "we want to eliminate it more or less completely").
Will it be available worldwide wide?

Remdesivir? It's already been approved of in the US, I think in Japan, too, and will probably be approved of in Europe soon. But so far, only as powder for intravenous therapy.
The EMA generally takes quite a bit longer than the FDA as there is quite a lot of bureaucracy involved. Considering the active substance is already approved for other purposes it should take less time but still... generally after the whole scientific part is done there are 25 days to finalise the wording, translate it, have it reviewed by every country’s medicines authority, and make any changes proposed by those authorities. Then the Commission takes around 2 months to finalise approval.

I expect we’ll be working with much tighter deadlines in this case but I don’t know how much the process can be speeded up.
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Re: Coronavirus disease 2019 (COVID-19)

Postby #12 » Wed Jun 10, 2020 7:06 pm

ramsej84 wrote:
RedQueen wrote:Learned in yesterdays Drosten Podcast that pharma companies are working on re-shaping Remdesivir into an inhalative medication, which could be given to patients in the very early stages when they're just starting to develop symptoms. Remdesivir according to Drosten is actually a drug that should be given in early stages, when the virus hasn't yet attacked other organs or caused overshooting immune reactions or other problems, because it's specifically designed to inhibit virus replication. By inhaling it, it could directly affect respiratory organs, without having to pass through digestive tract and the blood stream. If successful, this could prevent a lot of severe cases and deaths.

There's been a lot of hopeful news lately, to the point where science journalists in Germany are already arguing there's a chance we could eliminate the virus completely. Yesterday our health minister Spahn said in a presser "we want to nip the virus in the bud", which seems to indicate another change of strategy (from "we have to prevent a collapse of our health system", to "we want to control local outbreaks", to "we want to eliminate it more or less completely").
Will it be available worldwide wide?
Dude, this is not a war!

It most certainly will... It's also a means to make an awful lot of money...

Unless, of course, uncle Donald finds it first...
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Re: Coronavirus disease 2019 (COVID-19)

Postby #12 » Wed Jun 10, 2020 7:07 pm

FCBayernMunchen wrote:
RedQueen wrote:
ramsej84 wrote:[quote="RedQueen"]Learned in yesterdays Drosten Podcast that pharma companies are working on re-shaping Remdesivir into an inhalative medication, which could be given to patients in the very early stages when they're just starting to develop symptoms. Remdesivir according to Drosten is actually a drug that should be given in early stages, when the virus hasn't yet attacked other organs or caused overshooting immune reactions or other problems, because it's specifically designed to inhibit virus replication. By inhaling it, it could directly affect respiratory organs, without having to pass through digestive tract and the blood stream. If successful, this could prevent a lot of severe cases and deaths.

There's been a lot of hopeful news lately, to the point where science journalists in Germany are already arguing there's a chance we could eliminate the virus completely. Yesterday our health minister Spahn said in a presser "we want to nip the virus in the bud", which seems to indicate another change of strategy (from "we have to prevent a collapse of our health system", to "we want to control local outbreaks", to "we want to eliminate it more or less completely").
Will it be available worldwide wide?

Remdesivir? It's already been approved of in the US, I think in Japan, too, and will probably be approved of in Europe soon. But so far, only as powder for intravenous therapy.
The EMA generally takes quite a bit longer than the FDA as there is quite a lot of bureaucracy involved. Considering the active substance is already approved for other purposes it should take less time but still... generally after the whole scientific part is done there are 25 days to finalise the wording, translate it, have it reviewed by every country’s medicines authority, and make any changes proposed by those authorities. Then the Commission takes around 2 months to finalise approval.

I expect we’ll be working with much tighter deadlines in this case but I don’t know how much the process can be speeded up.[/quote]Well, as soon as they start throwing money at you you will translate like a madman
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Re: Coronavirus disease 2019 (COVID-19)

Postby FCBayernMunchen » Wed Jun 10, 2020 7:26 pm

Indeed I will. :lol:

No guarantee I’ll be the one working on it of course but there is a good chance as the EMA is my main livelihood. Most if not all of the Maltese versions are now done by me and a couple of colleagues I know well... which is a good thing, because the guys who did them before us absolutely sucked. Unfortunately we often have to work within their old and terrible wording.
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Re: Coronavirus disease 2019 (COVID-19)

Postby RedQueen » Wed Jun 10, 2020 7:31 pm

FCBayernMunchen wrote:
RedQueen wrote:Remdesivir? It's already been approved of in the US, I think in Japan, too, and will probably be approved of in Europe soon. But so far, only as powder for intravenous therapy.
The EMA generally takes quite a bit longer than the FDA as there is quite a lot of bureaucracy involved. Considering the active substance is already approved for other purposes it should take less time but still... generally after the whole scientific part is done there are 25 days to finalise the wording, translate it, have it reviewed by every country’s medicines authority, and make any changes proposed by those authorities. Then the Commission takes around 2 months to finalise approval.

I expect we’ll be working with much tighter deadlines in this case but I don’t know how much the process can be speeded up.

I actually think Remdesivir has never been fully approved of as a medication for Ebola, because it failed the clinical phase III test (due to not being effective). It's been used as an experimental drug for Covid under compassionate use in a number of countries, including the US and Germany, and since April it has been approved of in the US for hospitalized patients. I just saw that the company moved for approval to EMA only yesterday. Reports are talking about a couple of weeks.

But this is for intravenous use only, not for inhalation.
Last edited by RedQueen on Wed Jun 10, 2020 7:32 pm, edited 1 time in total.
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Re: Coronavirus disease 2019 (COVID-19)

Postby #12 » Wed Jun 10, 2020 7:32 pm

FCBayernMunchen wrote:Indeed I will. :lol:

No guarantee I’ll be the one working on it of course but there is a good chance as the EMA is my main livelihood. Most if not all of the Maltese versions are now done by me and a couple of colleagues I know well... which is a good thing, because the guys who did them before us absolutely sucked. Unfortunately we often have to work within their old and terrible wording.
Why can’t you change it?
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Re: Coronavirus disease 2019 (COVID-19)

Postby FCBayernMunchen » Wed Jun 10, 2020 7:43 pm

@RedQueen: you might be right. I was writing on my phone and simply searched whether there are existing documents and some came up so I assumed it’s approved for other indications, but I looked at them properly know and they are in fact early/preliminary documents for Covid-19.

@#12: if it’s a completely new medicine we can do whatever we like (within reason ) but most of the time it is either new info on an existing medicine, a new strength or form (tablets instead of injections for example), or a new medicine that is similar to an existing one. In the first two cases we can only touch the new text so we have to follow the existing terrible translations, although we make it a point to flag the problems up. Unfortunately unless they are a serious health hazard many pharma companies tend not to bother improving them though... particularly because Maltese doctors can easily turn to English. For the last case we would be obliged to follow the wording of the similar medicine.
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Re: Coronavirus disease 2019 (COVID-19)

Postby ramsej84 » Thu Jun 11, 2020 3:00 pm

Malta sticks to July 1 airport reopening plan, despite EU pressure
European Commission recommends internal borders reopen from Monday
NationalEuropean UnionHealthTourismTravel [source]


@the EU - f*ck off
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Re: Coronavirus disease 2019 (COVID-19)

Postby #12 » Thu Jun 11, 2020 3:06 pm

ramsej84 wrote:
Malta sticks to July 1 airport reopening plan, despite EU pressure
European Commission recommends internal borders reopen from Monday
NationalEuropean UnionHealthTourismTravel [source]


@the EU - f*ck off
What’s your problem? You realize there’s teachers everywhere in Europe teaching regular classes every day?
Your airport is not gonna have any effect...
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Re: Coronavirus disease 2019 (COVID-19)

Postby ramsej84 » Sat Jun 13, 2020 11:23 am

Parts of Beijing were placed under lockdown on Saturday as six new domestic coronavirus cases were reported, fuelling fears of a resurgence in local transmission. [source]


Fengtai district officials announced Saturday that the district has established a "wartime mechanism" and "field command centre" to deal with the fresh wave.

Nine nearby schools and kindergartens have been closed. On Friday, Beijing officials delayed the return of students to primary schools across the city, and suspended all sporting events and group dining. Cross-provincial tour groups were suspended on Saturday.
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Re: Coronavirus disease 2019 (COVID-19)

Postby ramsej84 » Sun Jun 14, 2020 9:34 am

Make sure to open back the borders you idiots....

https://timesofmalta.com/articles/view/ ... ons.798465

And also keep on letting the protests and looting going on .... keep it up
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Re: Coronavirus disease 2019 (COVID-19)

Postby Lukas » Sun Jun 14, 2020 11:22 am

That’s a bit depressing. Enjoy this temporary reprieve while it lasts I guess :(

Cases rising in Aus well. Somewhere that was supposed to have “done well”
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Re: Coronavirus disease 2019 (COVID-19)

Postby ramsej84 » Sun Jun 14, 2020 11:31 am

Lukas wrote:That’s a bit depressing. Enjoy this temporary reprieve while it lasts I guess :(

Cases rising in Aus well. Somewhere that was supposed to have “done well”
Australia or Austria?-
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Re: Coronavirus disease 2019 (COVID-19)

Postby Lukas » Sun Jun 14, 2020 11:34 am

ramsej84 wrote:
Lukas wrote:That’s a bit depressing. Enjoy this temporary reprieve while it lasts I guess :(

Cases rising in Aus well. Somewhere that was supposed to have “done well”
Australia or Austria?-

Australia. Apparently they’re still carrying on opening up though. Countries are now seeing others opening up and thinking they have to as they don’t want to be left behind. No doubt Australia are looking at NZ and thinking “well if they’re doing it we have to as well”
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Re: Coronavirus disease 2019 (COVID-19)

Postby FCBayernMunchen » Sun Jun 14, 2020 11:48 am

Lukas wrote:Australia. Apparently they’re still carrying on opening up though. Countries are now seeing others opening up and thinking they have to as they don’t want to be left behind. No doubt Australia are looking at NZ and thinking “well if they’re doing it we have to as well”

I wouldn't call less than 20 cases a day in a country as big as Australia concerning tbh, but yeah, states like WA which have almost eliminated it will likely reimport it when interstate travel resumes.

Malta has officially lifted all measures except flight restrictions, which will begin to ease to 21 countries (I believe) on 1st July and be lifted completely on the 15th. So as things stand we are a month away from having the same kind of laws/restrictions we had in January.
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