Another good post.
You wrote:
"But at the risk of sounding naive or ignorant, does Cytodyn really need the kind of sales staff, advertising, and manufacturing that Big Pharma employs? At this stage I would agree that “Cytodyn is not in a position to build out a proper go-to-market team.” But when news from successful trials hits, won’t patients and their relatives have people clamoring for this Next Great Drug? I mean, a metastatic-killing cancer drug with virtually no side effects? Part of the cure for HIV? Helps grandma think straight and remember what she said five minutes ago? Wowza! I would think it will sell itself, with Cytodyn left to coordinate the manufacturing (thank you Samsung!) and shipping product to pharmacies. Or instead of building out a sales and marketing team, can we just hire a company that specializes in that side of the pharmaceutical business?"
The answer to the first bolded question is yes, Cytodyn would need to mimic big pharma. Not because they're big pharma, but because that's what's necessary to bring a drug to market. There's a ton of regulatory issues to address on an ongoing basis and you have to be prepared to gather and share information with the fda in real time. Like if a doctor off-handedly says "I did try it with one patient but they had a reaction so I took them off of LL and a few other things to see if we could clear up what it was causing the problem" the rep has to report that to the company who in turn has to report that to the fda.
You need a team to negotiate with distribution channels and one to fight for coverage on insurance formularies. Because insurance's first instinct is to not cover something no matter how impressive the results were in the studies that gained it approval. You need a team to train reps on how to properly discuss your drug with doctors and pharmacists, and then another team to manage those same reps once they're released to their territories. It's a labor-intensive field. But on top of that, it's a very specialized kind of experience that you need across your entire team to be effective launching a drug.
But to your second point, there does exist third party companies who offer to help hire, train, and manage reps on your behalf. It's actually how I got my first gig in the industry way back when Kit-Kat's were still in the foil.
The issue there is that it's not the best way to go about things, save for the scenario where a company needs to rapidly expand but also doesn't want to have to pay severance should the reason for expanding fail at the market. Then it's on the third party company for unemployment benefits. There's a reason all these companies have their own people and use the third party companies sparingly.
So it's not impossible to either try to go after it alone, or to try to use a third party. But it's not the ideal way to go. And the complex nature of the business combined with the labor necessary to pull it off means that to go from where Cytodyn is now to where it would need to be is a pretty astronomical leap.
Later you wrote:
"I’d love to see Cytodyn go it alone as I’m skeptical how a Gilead or Merck would develop leronlimab."
There's no better industry at milking every last drop out of a product than pharmaceutical sales. They'll extend indications into other disease states, create new formulations or delivery mechanisms, our branch out into pediatrics to keep the exclusivity and gravy train rolling. They live and breath for platform drugs. Early in development I'm sure they'd love to see Cytodyn go away, and though we won't ever know for sure it wouldn't surprise me if they had a hand in making the road difficult. But now LL is much closer to the land of approvals with way more data backing up it's potential (with even more data on its way) and like a short should shift a long at some point, they're going to be serious about being the one to market LL. They know full well when their current gravy train is set to stop and how that will affect their bottom line. They're going to back up the trucks for this one because that's where we're at now.
When we get to the point (which we realistically should at any moment) where someone drops big cash to license LL for an indication that currently doesn't have any answers for patients, that company will be salivating to get LL across the line and be the first to market with a real, beneficial drug. And from there they'll know it's a platform drug and have to buy us out before it's too expensive. At that point you'll see a decades long push to get LL out in as many ways and for as many indications as possible, because that's where the money is.
Also, they have to provide value to their shareholders and if the options are destroy everything to keep a measly three years of exclusivity rolling strong or back up their fading thoroughbred with the next Secretariat I think they're smart enough to know which scenario is more valuable to them in the long run.
The pharma world is lousy with drugs that were better than other drugs but couldn't break through for a variety of reasons. Which is why going after it alone is risky. I believe our best bet is to hitch our wagon to one of the big boys. That being said, there's room for things like becoming a subsidiary and having the parent company load up Cytodyn's HQ with the firepower they need to control some of LL's future but still ultimately fall under the purview of their parent company. The only problem for Cytodyn is that these companies need LL. They don't need Cytodyn's people, as good as we may think they are.
But that's all just how I see it. And if you'd asked me a handful of times over the years to predict how things would or should go with LL and/or its approval potential or timing, I'd have been wrong. A LOT.
You wrote:
"But at the risk of sounding naive or ignorant, does Cytodyn really need the kind of sales staff, advertising, and manufacturing that Big Pharma employs? At this stage I would agree that “Cytodyn is not in a position to build out a proper go-to-market team.” But when news from successful trials hits, won’t patients and their relatives have people clamoring for this Next Great Drug? I mean, a metastatic-killing cancer drug with virtually no side effects? Part of the cure for HIV? Helps grandma think straight and remember what she said five minutes ago? Wowza! I would think it will sell itself, with Cytodyn left to coordinate the manufacturing (thank you Samsung!) and shipping product to pharmacies. Or instead of building out a sales and marketing team, can we just hire a company that specializes in that side of the pharmaceutical business?"
The answer to the first bolded question is yes, Cytodyn would need to mimic big pharma. Not because they're big pharma, but because that's what's necessary to bring a drug to market. There's a ton of regulatory issues to address on an ongoing basis and you have to be prepared to gather and share information with the fda in real time. Like if a doctor off-handedly says "I did try it with one patient but they had a reaction so I took them off of LL and a few other things to see if we could clear up what it was causing the problem" the rep has to report that to the company who in turn has to report that to the fda.
You need a team to negotiate with distribution channels and one to fight for coverage on insurance formularies. Because insurance's first instinct is to not cover something no matter how impressive the results were in the studies that gained it approval. You need a team to train reps on how to properly discuss your drug with doctors and pharmacists, and then another team to manage those same reps once they're released to their territories. It's a labor-intensive field. But on top of that, it's a very specialized kind of experience that you need across your entire team to be effective launching a drug.
But to your second point, there does exist third party companies who offer to help hire, train, and manage reps on your behalf. It's actually how I got my first gig in the industry way back when Kit-Kat's were still in the foil.
The issue there is that it's not the best way to go about things, save for the scenario where a company needs to rapidly expand but also doesn't want to have to pay severance should the reason for expanding fail at the market. Then it's on the third party company for unemployment benefits. There's a reason all these companies have their own people and use the third party companies sparingly.
So it's not impossible to either try to go after it alone, or to try to use a third party. But it's not the ideal way to go. And the complex nature of the business combined with the labor necessary to pull it off means that to go from where Cytodyn is now to where it would need to be is a pretty astronomical leap.
Later you wrote:
"I’d love to see Cytodyn go it alone as I’m skeptical how a Gilead or Merck would develop leronlimab."
There's no better industry at milking every last drop out of a product than pharmaceutical sales. They'll extend indications into other disease states, create new formulations or delivery mechanisms, our branch out into pediatrics to keep the exclusivity and gravy train rolling. They live and breath for platform drugs. Early in development I'm sure they'd love to see Cytodyn go away, and though we won't ever know for sure it wouldn't surprise me if they had a hand in making the road difficult. But now LL is much closer to the land of approvals with way more data backing up it's potential (with even more data on its way) and like a short should shift a long at some point, they're going to be serious about being the one to market LL. They know full well when their current gravy train is set to stop and how that will affect their bottom line. They're going to back up the trucks for this one because that's where we're at now.
When we get to the point (which we realistically should at any moment) where someone drops big cash to license LL for an indication that currently doesn't have any answers for patients, that company will be salivating to get LL across the line and be the first to market with a real, beneficial drug. And from there they'll know it's a platform drug and have to buy us out before it's too expensive. At that point you'll see a decades long push to get LL out in as many ways and for as many indications as possible, because that's where the money is.
Also, they have to provide value to their shareholders and if the options are destroy everything to keep a measly three years of exclusivity rolling strong or back up their fading thoroughbred with the next Secretariat I think they're smart enough to know which scenario is more valuable to them in the long run.
The pharma world is lousy with drugs that were better than other drugs but couldn't break through for a variety of reasons. Which is why going after it alone is risky. I believe our best bet is to hitch our wagon to one of the big boys. That being said, there's room for things like becoming a subsidiary and having the parent company load up Cytodyn's HQ with the firepower they need to control some of LL's future but still ultimately fall under the purview of their parent company. The only problem for Cytodyn is that these companies need LL. They don't need Cytodyn's people, as good as we may think they are.
But that's all just how I see it. And if you'd asked me a handful of times over the years to predict how things would or should go with LL and/or its approval potential or timing, I'd have been wrong. A LOT.
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