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Posted On: 09/21/2021 10:43:11 PM
Post# of 148899
“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.”
If the trial produces data that can persuade Brazil to authorize sales, then our troubles are behind us.
It doesn’t matter if our margins are thinner there. Regulatory approval validates the drug. That’s the victory. Other countries (lPhilippines, Mexico, and India, etc.) would surely be more amenable to us. We could pay off our debt to Samsung and build a runway to pursue our other indications (including covid in US, if the FDA balks at the Brazil data). Skeptical investors would finally climb on the bandwagon, and the (much) higher share price would make equity raises far less dilutive.
All of this strikes me as a very high probability outcome from success in Brazil. And I am extremely confident of success in Brazil.
In that case, what do I need 13d for? And why would I consider handing this hard-fought victory to them?
Maybe after success in Brazil, and from a position of unassailable strength, we might consider giving Bruce the chance to contribute his diagnostic and virologic expertise, perhaps as a consultant, and only in a very, very short leash.
The rest of 13d can go f*** themselves bloody.
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.”
If the trial produces data that can persuade Brazil to authorize sales, then our troubles are behind us.
It doesn’t matter if our margins are thinner there. Regulatory approval validates the drug. That’s the victory. Other countries (lPhilippines, Mexico, and India, etc.) would surely be more amenable to us. We could pay off our debt to Samsung and build a runway to pursue our other indications (including covid in US, if the FDA balks at the Brazil data). Skeptical investors would finally climb on the bandwagon, and the (much) higher share price would make equity raises far less dilutive.
All of this strikes me as a very high probability outcome from success in Brazil. And I am extremely confident of success in Brazil.
In that case, what do I need 13d for? And why would I consider handing this hard-fought victory to them?
Maybe after success in Brazil, and from a position of unassailable strength, we might consider giving Bruce the chance to contribute his diagnostic and virologic expertise, perhaps as a consultant, and only in a very, very short leash.
The rest of 13d can go f*** themselves bloody.
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