For me, manufacturing is a multi-issue.
$18m.
Even if the full amount was directed to a manufacturing readiness, that would not even scratch the interest from a manufacturer, for marketing / sales.
Think about this: Our LL batches for trials are very likely either expired & or, need to be replenished. Trial LL, is different than marketing LL. Which is when it would (guessing of course), relate to Dr. J comment of imagining Cytodyn, will not market, the drug ourselves.
So a reverse look for me reading it today :
The Compassionate Use, has to be 1st approved by the actual manufacturer of LL. 2nd is FDA. 3rd Cytodyn.
The FDA can, later Use the manufacturers LL trial manufacturing, as the lead into approving LL manufacturing for marketing.Whoever is manufacturing our trial batches, is of course very likely going to be the manufacturer later, after full approval --- or at least an AA sales, if AA is request/granted via whichever route, etc...
I took today's comment as Cytodyn gearing up for non-marketing manufacturing of LL. With including starting the route of later submitting this manufacturer to FDA for selling LL.
A side note --- Creativ Bio can also FDA request using the current LL trials, too for marketing sales approval, for cancers. Right now they are "only" approved @ R&D, etc.... I've had fingers crossed it's a way Cytodyn leverages an equity stake on all Creativ's assays of LL.
Shall see....alot of moving parts
$18m.
Even if the full amount was directed to a manufacturing readiness, that would not even scratch the interest from a manufacturer, for marketing / sales.
Think about this: Our LL batches for trials are very likely either expired & or, need to be replenished. Trial LL, is different than marketing LL. Which is when it would (guessing of course), relate to Dr. J comment of imagining Cytodyn, will not market, the drug ourselves.
So a reverse look for me reading it today :
The Compassionate Use, has to be 1st approved by the actual manufacturer of LL. 2nd is FDA. 3rd Cytodyn.
The FDA can, later Use the manufacturers LL trial manufacturing, as the lead into approving LL manufacturing for marketing.Whoever is manufacturing our trial batches, is of course very likely going to be the manufacturer later, after full approval --- or at least an AA sales, if AA is request/granted via whichever route, etc...
I took today's comment as Cytodyn gearing up for non-marketing manufacturing of LL. With including starting the route of later submitting this manufacturer to FDA for selling LL.
A side note --- Creativ Bio can also FDA request using the current LL trials, too for marketing sales approval, for cancers. Right now they are "only" approved @ R&D, etc.... I've had fingers crossed it's a way Cytodyn leverages an equity stake on all Creativ's assays of LL.
Shall see....alot of moving parts
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