(Total Views: 505)
Posted On: 09/21/2021 11:19:42 PM
Post# of 154803
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The Proxy Group definitely prioritized Longhaulers ahead of the Brazil Covid trials in terms of potential and speed to strong revenue.
Which shows a bit of idiocy. With longhaulers being a brand new indication for the FDA the phase 2 trial will probably be quite a bit longhauler. Top that off with the time it takes for a full approval vs. EUA. But hey it might mean Patterson can sell a few more test kits.
They'd rather burn another 9 months of cash waiting for longhaulers rather than prioritizing Covid-19 trials.
Not to mention that having an EUA approval before a full approval is the best possible thing to happen. Don't they think anything through?
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1. Actual revenue potential from sales in Brazil vs costs.
Which shows how short-sighted and dunderheaded their thinking is. Brazil is a springboard to EUAs elsewhere.
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The FDAs willingness to issue a US approval based on Brazil results - this is probably the key question.
Will they approve just on trial results? If they try to screw us again they will have to rethink the matter. With approval elsewhere and success stories popping up in the press, Media will be questioning them as to why they haven't approved a drug with positive trial results.
Once again they have a limited viewpoint that doesn't take into account reality.
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Some concerns with trail design and endpoints, but more based on not having all the information than clearly having a concern
They don't have the data in order to make a proper judgement.
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Dr Patterson said the LH trial could go so fast that they could have it completed and US FDA approval by mid-2022
It will depend on what trial length the FDA insists on. I can't see less than 3 months and it could be 6 months. I wouldn't expect approval before Q3 2022. Then you get into Patterson probably centering the protocol around his pet theory for longhaulers. That could be a recipe for disaster.
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