I was trading some private messages with one of my favorite board members and he suggested I post one in particular so everyone could see it. I won't give you his name, to keep his identity private. I'll just call him BenMulligatawny.
Anyways, here goes. It's on the subject of why we're still sitting on our hands waiting for a PR. It's long. I regret nothing.
Hello!
Yeah, it's a little frustrating to know that NP threw out mid January on, I think, more than one occasion. Like everyone else, I'm also of the opinion that the minute the data is unblinded they can run the primary endpoint calculation and know if we're going to get approval. So it does make me sweat a little believing these things to be true and sitting on the verge of the end of January with no news. NP has gotten a lot better over the last 3-4 months but he hasn't fully learned or we wouldn't have had the last conference call and he wouldn't have given a date range he couldn't hit.
But I think the delay is for three reasons.
First, the task of compiling and assessing the trial results from all of the facilities does appear to be a slow moving process. We had to wait longer than NP thought for the M to M trial to finally lock and we have way more sites and patient information to deal with. I think he way overestimated how smoothly and, as a result, quickly it would go. Those in the know claim that there is often a lot of back and forth communication with sites before everything can be considered lockable. I don't know specifically what or why that would be the case, but it appears to be noted by many who claim to be involved with clinical trials. So I think that has had an impact on timing.
Next, and we may never know for sure, but I wonder if Mahboob has influenced NP to go slow and steady rather than fast and furious. He seems the type and if so it wouldn't surprise me that they're triple-checking everything and building the strongest case possible before announcing anything. As to avoid failure or delay on a technicality, which we seem to be pretty good at.
Lastly, we're at a point where so much hinges on the results of this trial that some amount of additional time to negotiate, partner, or strategize is likely necessary. I still think NP is preparing us to be as valuable as possible in case someone tries to make an offer. I think he wants an offer, but only a very substantial one. Which is why he's always trying to move things along quickly (if we can get 5 patients past 6 months we can go for breakthrough designation!) But if/when that can't occur because we're too expensive we'll be sitting on a tremendous share price and off to the races by ourselves. That's also a pretty good place to be. Probably a better one, though if someone wanted to give me $128 dollars a share today I'd be happy to sell.
I've really been thinking a lot lately about the positive fallout from good results and how that will impact the announcements. If they run the calculation immediately and it's a slam dunk, shouldn't they first go to the FDA and share that information in hopes of lining up OWS funds and approval? That would take some time to negotiate. All while continuing to analyze secondary endpoints and any nuggets of efficacy hidden within. I'd love to know immediately because I've got money on the line, but that one bit of information changes the direction and speed of many other opportunities.
They should be sharing early results with potential partners right away, maybe even with potential suitors if there are any. They should be strategizing four and five steps ahead, laying the groundwork for approvals in other countries and partnerships with local distributor or pharma partners where necessary. None of that goes quickly. I'm hopeful there are some big things that will occur as the result of a stat sig reduction in death. Hopefully getting their ducks in a row is part of the slowdown.
Maybe the results are good but not amazing. Perhaps Mahboob/NP would want to shore that information up with all of the secondary enpoint information to make a stronger case. Maybe it's amazing and they're negotiating with OWS and the FDA right now about how to proceed and it hasn't been finalized.
Honestly, I think it's mostly just a lot more information to compile and it's going slower than they anticipated for reasons unrelated to whether it works or not. But I would also bet money that they're trying to put together a PR that is more than just results and need extra time.
I also wonder whether or not there has been a little delay due to the administration changing. Perhaps the disruption of people moving on/out and new people coming on board has delayed negotiations slightly. Though I was disheartened with the comments from fauci and the white house days ago where they all but said there's nothing new on the treatment side right now.
Makes me furious that we continue to get zero mention from them and also brings up that little voice in the back of my head saying "they don't plan to make it easy, maybe they'll ask for a second trial to confirm the first trial's results. Or find some other way to delay things."
When all of a sudden there's another injectable for HIV recently getting approved from a big pharma company I couldn't help but think that latest delays have been around letting a friend get to market first. Although it technically (supposedly, I am taking the word of others on these boards) doesn't directly compete with us I can see there being reasons getting it market first would be important. Doctors are creatures of habit and before they have a chance to try some brand new injectable from Cytodyn and completely change how they treat patients perhaps they'll be told all about this new injectable containing drugs they're already comfortable and confident with.
Man, I just went back through and read this to make sure there weren't any glaring errors and if it were NaNoWriMo I'd have maybe exceeded my daily word count.
I do have someone I've been in touch with that is involved with clinical trials and they said this, echoing what many have said across the message boards worth reading:
"Data lock, verification, it takes time, lots of back and forth because of queries, but once that itty bitty detail gets cleaned up, you'll be one step closer. They'll do it right the first time, they'll take the appropriate amount of time. Once it's done, analyzed, vetted, they will pass it asap to FDA."
Kind of generic but I'm holding it tightly and giving NP and the crew a little slack for now. If it gets to be the first week of February with nothing I may start to get more worried. But even then, I would just find it hard to believe Leronlimab didn't work. What would have been the point of the DSMC letting us continue if it wasn't on track?
Signed,
ClearAsMud
Anyways, here goes. It's on the subject of why we're still sitting on our hands waiting for a PR. It's long. I regret nothing.
Hello!
Yeah, it's a little frustrating to know that NP threw out mid January on, I think, more than one occasion. Like everyone else, I'm also of the opinion that the minute the data is unblinded they can run the primary endpoint calculation and know if we're going to get approval. So it does make me sweat a little believing these things to be true and sitting on the verge of the end of January with no news. NP has gotten a lot better over the last 3-4 months but he hasn't fully learned or we wouldn't have had the last conference call and he wouldn't have given a date range he couldn't hit.
But I think the delay is for three reasons.
First, the task of compiling and assessing the trial results from all of the facilities does appear to be a slow moving process. We had to wait longer than NP thought for the M to M trial to finally lock and we have way more sites and patient information to deal with. I think he way overestimated how smoothly and, as a result, quickly it would go. Those in the know claim that there is often a lot of back and forth communication with sites before everything can be considered lockable. I don't know specifically what or why that would be the case, but it appears to be noted by many who claim to be involved with clinical trials. So I think that has had an impact on timing.
Next, and we may never know for sure, but I wonder if Mahboob has influenced NP to go slow and steady rather than fast and furious. He seems the type and if so it wouldn't surprise me that they're triple-checking everything and building the strongest case possible before announcing anything. As to avoid failure or delay on a technicality, which we seem to be pretty good at.
Lastly, we're at a point where so much hinges on the results of this trial that some amount of additional time to negotiate, partner, or strategize is likely necessary. I still think NP is preparing us to be as valuable as possible in case someone tries to make an offer. I think he wants an offer, but only a very substantial one. Which is why he's always trying to move things along quickly (if we can get 5 patients past 6 months we can go for breakthrough designation!) But if/when that can't occur because we're too expensive we'll be sitting on a tremendous share price and off to the races by ourselves. That's also a pretty good place to be. Probably a better one, though if someone wanted to give me $128 dollars a share today I'd be happy to sell.
I've really been thinking a lot lately about the positive fallout from good results and how that will impact the announcements. If they run the calculation immediately and it's a slam dunk, shouldn't they first go to the FDA and share that information in hopes of lining up OWS funds and approval? That would take some time to negotiate. All while continuing to analyze secondary endpoints and any nuggets of efficacy hidden within. I'd love to know immediately because I've got money on the line, but that one bit of information changes the direction and speed of many other opportunities.
They should be sharing early results with potential partners right away, maybe even with potential suitors if there are any. They should be strategizing four and five steps ahead, laying the groundwork for approvals in other countries and partnerships with local distributor or pharma partners where necessary. None of that goes quickly. I'm hopeful there are some big things that will occur as the result of a stat sig reduction in death. Hopefully getting their ducks in a row is part of the slowdown.
Maybe the results are good but not amazing. Perhaps Mahboob/NP would want to shore that information up with all of the secondary enpoint information to make a stronger case. Maybe it's amazing and they're negotiating with OWS and the FDA right now about how to proceed and it hasn't been finalized.
Honestly, I think it's mostly just a lot more information to compile and it's going slower than they anticipated for reasons unrelated to whether it works or not. But I would also bet money that they're trying to put together a PR that is more than just results and need extra time.
I also wonder whether or not there has been a little delay due to the administration changing. Perhaps the disruption of people moving on/out and new people coming on board has delayed negotiations slightly. Though I was disheartened with the comments from fauci and the white house days ago where they all but said there's nothing new on the treatment side right now.
Makes me furious that we continue to get zero mention from them and also brings up that little voice in the back of my head saying "they don't plan to make it easy, maybe they'll ask for a second trial to confirm the first trial's results. Or find some other way to delay things."
When all of a sudden there's another injectable for HIV recently getting approved from a big pharma company I couldn't help but think that latest delays have been around letting a friend get to market first. Although it technically (supposedly, I am taking the word of others on these boards) doesn't directly compete with us I can see there being reasons getting it market first would be important. Doctors are creatures of habit and before they have a chance to try some brand new injectable from Cytodyn and completely change how they treat patients perhaps they'll be told all about this new injectable containing drugs they're already comfortable and confident with.
Man, I just went back through and read this to make sure there weren't any glaring errors and if it were NaNoWriMo I'd have maybe exceeded my daily word count.
I do have someone I've been in touch with that is involved with clinical trials and they said this, echoing what many have said across the message boards worth reading:
"Data lock, verification, it takes time, lots of back and forth because of queries, but once that itty bitty detail gets cleaned up, you'll be one step closer. They'll do it right the first time, they'll take the appropriate amount of time. Once it's done, analyzed, vetted, they will pass it asap to FDA."
Kind of generic but I'm holding it tightly and giving NP and the crew a little slack for now. If it gets to be the first week of February with nothing I may start to get more worried. But even then, I would just find it hard to believe Leronlimab didn't work. What would have been the point of the DSMC letting us continue if it wasn't on track?
Signed,
ClearAsMud
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