Coronovirus IV

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    nonobaddog

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    Mar 10, 2015
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    And of limited value. The drug was shown to reduce hospital stays, but not save a single life.

    Seems expensive for very little gain. Every statement I have seen is very guarded about saying anything about an unqualified benefit. Lots of 'may do this', 'might do that', 'appears to help'.
    Seems to be political push is the main driving force behind this nothing burger.
     

    T.Lex

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    Mar 30, 2011
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    Seems expensive for very little gain. Every statement I have seen is very guarded about saying anything about an unqualified benefit. Lots of 'may do this', 'might do that', 'appears to help'.

    Which puts it in good company with all the bazillion prescription drugs I see advertised on TV.
     

    BugI02

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    Jul 4, 2013
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    Doing mental back-of-napkin calculations, that ($520/vial) is going to be pretty close to selling it at-cost. That's barely going to cover the capital investment costs incurred to ramp up manufacturing.

    So, are those first free 500k (IIRC) doses actually a donation? Or will they simply recoup the costs as part of that 'ramp up manufacturing' investment cost accounting. This was a stranded drug developed for ebola treatment, so why are the development/manufacturing costs so high (unless they are also recouping the costs stranded in the ebola research)? It smells
     

    JettaKnight

    Я з Україною
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    Oct 13, 2010
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    Moving from drugs to virus spread...

    For those watching this - How did Sweden do compared to other places? Their strategy was substantially more live and let live, so did it pay off?
     

    Alpo

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    Sep 23, 2014
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    Moving from drugs to virus spread...

    For those watching this - How did Sweden do compared to other places? Their strategy was substantially more live and let live, so did it pay off?

    No. Not compared with Switzerland, which was my other benchmark country.

    Sweden: 5300 deaths. Swiss: 2000
     

    T.Lex

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    Moving from drugs to virus spread...

    For those watching this - How did Sweden do compared to other places? Their strategy was substantially more live and let live, so did it pay off?

    I believe they are running about 520 deaths per million, and we're running under 400. But that's just one metric.
     

    chipbennett

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    Oct 18, 2014
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    So, are those first free 500k (IIRC) doses actually a donation? Or will they simply recoup the costs as part of that 'ramp up manufacturing' investment cost accounting. This was a stranded drug developed for ebola treatment, so why are the development/manufacturing costs so high (unless they are also recouping the costs stranded in the ebola research)? It smells

    Gilead makes the API only. They don't manufacture the finished drug product (or, at least, they don't have the fill-finish manufacturing capacity to supply the anticipated demand). All of the R&D goes into the API, more or less. Capital investment goes into the finished dosage form (there is some capital cost for pilot-plant scale-up, but for the most part, a pilot plant is a pilot plant). So, Gilead makes the API (the active ingredient - analogous to the ibuprofen in Advil), and then sends it to contract manufacturing organization (CMO), who performs the fill-finish manufacturing (compounding the api with other ingredients, filling/finishing the dosage form, then packaging it. (N.B. one such CMO is where I have been working since April, helping them convert their facility to be able to fill-finish Remdesivir).

    Remdesivir is a parenteral (injected) dosage form, which means the fill-finish manufacturing must be aseptic - which, in turn, is a rather extensive and expensive process. I could go into general detail, but I don't want to bore everyone. Suffice it to say, everything from stem to stern must be free of any living organisms or their leftovers (endotoxins), and must be maintained in that state until the finished product is in its final, sealed container-closure form. Also, as a parenteral dosage form, it is a lyophilized (a type of freeze drying that makes the product more stable and easier to reconstitute for administration) product. Lyophilization itself is a long, expensive process. (N.B. this has been my area of focus for this site, preparing existing lyophilizers for the Remdesivir process and driving completion of qualification of additional lyophilizers for production ramp up after approval.)

    Long story short: there are multiple CMOs, and getting them ready and ramping them up incurs a significant capital investment. My one little piece (qualification of the lyophilizers) is a seven-figure scope of work. And that doesn't even get into the actual cost of manufacturing a vial of the product.

    As for the initial, free doses: I have no clue what Gilead will do from an accounting perspective. I assume it would be a write-off. Based on the per-vial cost for later supply, they're certainly not spiking the price to recoup earlier manufacturing (much less, R&D) costs.
     
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