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Posted On: 09/21/2021 9:51:56 PM
Post# of 154775
One other key matter from the call.
The Proxy Group definitely prioritized Longhaulers ahead of the Brazil Covid trials in terms of potential and speed to strong revenue.
They said a couple of times that, of course, they would continue Brazil if enrollment and interims were on track. But they also expressed some concerns with:
1. Actual revenue potential from sales in Brazil vs costs.
2. The FDAs willingness to issue a US approval based on Brazil results - this is probably the key question......If FDA goes along with Brazil, then big win....if not, then not so much.
3. Some concerns with trail design and endpoints, but more based on not having all the information than clearly having a concern
In summary, they basically said that Brazil could be great, but they aren't counting on it. But, they aren't eliminating the possibility.
Dr Patterson said the LH trial could go so fast that they could have it completed and US FDA approval by mid-2022. Seems overly optimistic, but that is what they all discussed.
I see the above issue as an area where many members of this message board will have a major difference of opinion with the Proxy Group.
The Proxy Group definitely prioritized Longhaulers ahead of the Brazil Covid trials in terms of potential and speed to strong revenue.
They said a couple of times that, of course, they would continue Brazil if enrollment and interims were on track. But they also expressed some concerns with:
1. Actual revenue potential from sales in Brazil vs costs.
2. The FDAs willingness to issue a US approval based on Brazil results - this is probably the key question......If FDA goes along with Brazil, then big win....if not, then not so much.
3. Some concerns with trail design and endpoints, but more based on not having all the information than clearly having a concern
In summary, they basically said that Brazil could be great, but they aren't counting on it. But, they aren't eliminating the possibility.
Dr Patterson said the LH trial could go so fast that they could have it completed and US FDA approval by mid-2022. Seems overly optimistic, but that is what they all discussed.
I see the above issue as an area where many members of this message board will have a major difference of opinion with the Proxy Group.
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