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Misiu143 what do you think chances are we hear something about 28 this week? Do you think that they will have had 4 injections by end of this week? What are you realistically hoping for in the results?
Exactly! "or risk leronlimab being controlled from elsewhere with serious vicious consequences to their revenue streams". A BO or partnership from a company headquartered in a country that doesn't give a rats a## about the FDA not only would bring a serious bump in sp, but the future would be bright as well. I think this would be the best solution for all involved, as patients would be able to receive the therapeutics that they need, and other countries would not hesitate to order leronlimab for fear of the FDA imo.
If leronlimab was able to be used in India, their oxygen shortage would be relieved imo. I hope and pray that India will not let procedure and politics stop them from trying to save their citizens.
That was said last weekend. Until a contract signed I believe sp languishes. If sales are one hospital at a time, it will be a slow go. We need a EUA announcement of some kind to get things started imo.
Should be, but I'm gonna take a wait and see attitude. I believe the only thing that will have impact on sp is revenue. There are so many big players trying to keep this down, that until volume gets about 10x what we've seen lately, I think it will continue to waffle imo.
Brazil and India won't ask for leronlimab imo. I believe that the US FDA has seen what the Philippines has done with their CSP program, and how it could snowball if not kept in check. I truly think that there have been calls to heads of state from US about not killing the goose that laid the golden egg, and regardless of what you think, that carries a lot of weight worldwide. I hope that the Philippines follows through with their plan as I believe many thousands of people will benefit, but even their government coincided that they knew where their money came from when I watched the video. It would be nice to be wrong, but Fauci wants to make his millions with Moderna and he will do anything to do so imo.
When will word about sales in Philippines get out do you think? Do you think there will be a pr as to a sale of 200,000 vials, or will we see something along the lines that Chiral is filling sales request to various hospitals with no set number? If the later, I don't see much of a pop is sp as it is too ambiguous. I would like to see something more substantial about Brazil, rather than just a distribution agreement with no sales numbers.
And it's in writing in the notes!
I think US FDA didn't foresee csp as a threat. The fact that the Philippine government has allowed hospitals to bulk order, which has potential not only to save multitudes of lives, but bring significant revenue to CytoDyn was not part of the plan. This may also bring pressure to bear regarding a EUA with them, and now Brazil, Canada, Hungary I believe are potential customers, as they can see the safety and efficacy. At that point there may be serious inquires regarding BO, imo.
Anybody think pr regarding csp orders to Chiral forthcoming?
Hard for Philippines not to give EUA if in the near future there are 1000's of individuals who are leaving the hospital because of leronlimab imo.
I am hopeful that the csp protocol provides an end run so to speak around the FDA. It provides life saving therapeutics as well as revenue that could become significant with hospitals being allowed to bulk order. This may be a situation that the US FDA did not forsee. I'm sure they know that if they don't give EUA, neither will the Philippines. However it appears that human lives seem to matter to individuals that make decisions there, and allowing the csp to have ease of access to leronlimab not only benefits the patients, but takes their government off the hook, in that they can say all the responsibility lies with the physicians and hospitals. They can say they still didn't give EUA, but listening to the meeting where they agreed to allow hospitals to order and stockpile, bodes well for CytoDyn imo. Now all that needs to happen is for Brazil to follow suit.
Yes Latane, that is my hope and prayer as well. The designation is irrelevant, as long as people's lives are saved and revenue is generated for CytoDyn.
So if over 250 with one at a time request, in the short period of time csp has been in effect, imagine how much more now that hospitals can order in bulk!
I doubt Remdesivir or Lenzilumab will be considered by physicians for csp often, if the physician has to take responsibility for the results. I know I wouldn't. Amazing that leronlimab is so safe and effective compared to SOC, yet people continue to bash. I hope leronlimab achieves worldwide acceptance, so the goal of saving lives is once again the goal imo.
I believe the CSP protocol is huge benefit to leronlimab. It is so safe that physicians don't have to worry about repercussions from SAE, so they are willing to prescribe, and the benefits are so great that population knows it will save lives and they will demand it imo. I thought that it would take longer to see benefit, but the Philippines are a resilient people, and care not for politics and procedure, just get it done, appears to be their motto imo. Refreshing.
Yes, but 2-3 weeks is the time frame I give it, because I believe Brazil is closely watching the Philippines and seeing how everything is being expedited. The FDA is also watching imo and if results with IV for first dose, followed by 3 injections proves to have an overwhelming positive effect, I see a EUA in the cards. Then look out as I think at this point CytoDyn will have many suitors for partnership and the sp will skyrocket imo.
It would be wonderful if leronlimab would be allowed to help save lives imo.
Will CytoDyn seek csp with Brazil as well do you think, or is Brazil in a place they can give EUA for their country?
Yes you can call me "dad" and I hope as well that the circumstances of their people dying of some of these smaller countries, preclude any allegiance they may feel toward the FDA. People's lives should be held in utmost respect, and perhaps the culture of some of these countries that are experiencing the worst of this plague will push them to protect their citizens imo.
masshyateria, thank you for your response. I agree that should a EUA of a foreign country be granted, it could create a fomo attitude among investors. However I just think the FDA and BP has such a hold on these smaller countries, (Philippines received billions from US to buy vaccines and therapeutics) that I feel that they don't want to get too far from the feeding trough. At best I think a CSP type program, where purchases are in the hundreds at a time of vials, rather than the hundreds of thousands will be all we see. Yes it will be revenue, but nothing of magnitude. I believe until a BO or partner with BP, Cytodyn will struggle to move the sp much imo.
Yes, that is a good time frame. So any sp appreciation near term will be from sales to Brazil, Canada, or Philippenes or whoever. So it seems there will be no "pop" in sp because of a particular pr, but rather an accumulation of countries participating in a csp type of program imo. This is ok, but I believe it will allow more manipulation by shorts and should the sp rise, it will be slow and with resistance.
Richard S Nicolas MD
Dieselpro, do you think a Canadian I/O would have the same effect on other countries considering purchasing leronlimab as a EUA from US FDA would?
Think we hear about the 28 this week?
FDA should give EUA so other countries who are so inundated with covid cases could buy leronlimab and not have to struggle with putting peoples lives ahead of procedure and get the people out of the hospital. The FDA should feel a burden to help humanity, and doing this could potentially save millions of lives imo.
So Remdesivir is giving their's away?
Dieselpro do you think we get a pr this week concerning the Philippines?
There wouldn't be need for a 8k for sales, would there? If this is an ongoing situation where Chiral is supplying leronlimab at the request of different physicians or hospitals, I would think a simple pr stating that sales are being done to provide for the CSP request. Would you care to venture a guess as to how much might be requested?
Thank you misiu143. I believe this will only strengthen the resolve of the doctors and hospitals to obtain leronlimab. I read that a CSP provides for a doctor or a hospital to purchase it, could this be done for multiple patients at one time? I was wondering if a hospital could take the number of patients that have covid 19, and then multiple it by 4 and order that amount, or do they have to do it one patient at a time? Would you know?
I agree, especially if sales for CSP are pr'd. I wonder if Brazil has something similar to CSP for their drug approval. I'm sure they are watching closely what's going on in the Philippines.
"Granted to physician's or hospitals". It allows hospitals to order and I imagine it won't be for just one patient at a time. After data appears from 28 now getting it, I believe the hospitals will be ordering in bulk. The thought that this is a " one off" implying low volume, is not seeing the truck coming at you at 90 miles an hour imo.
Any guesses when pr for 200,000 vials sold?
4 week phase 4 would start in May. I think that's possible if both Philippines and Brazil purchase leronlimab under CSP. EUA could be given first of May with phase 4 confirmatory trial to run conjunctively with them.
"Remedesivir is used under Compassionate Special Permit" I seriously doubt that it's being given away.
Exactly, EUA has not been mentioned, but CSP has to the tune of 200,000 vials. Money is money, regardless of what the program is called.
"Chiral is continuously receiving CSP request". Is this revenue?
Is a CSP the same as EUA? In the pr in seemed to indicate that the direction was to allow hospitals to order in bulk of leronlimab. Is this the wrong understanding? Or would the government order it, then give it out as requested? What is anybody's guess as the timeframe this takes place?
Exactly! "If safe, and shows potential benefit" don't people understand? The safety is beyond question, I believe that the CD10 study showed it is safer than placebo, as it perhaps improved some of the patients underlying conditions. The SAE was less with leronlimab than with placebo, go figure. It should be obvious that it has potential benefit, as 82% of the critical over 65 improved vs placebo. EUA NOW!!! imo
C-20 this is why I really do pray for a BO. If it doesn't happen untold numbers of people may suffer and die because of lack of access. I am beyond words when I think of what might have been if not for NP and his pride. However since I honestly believe in the science, perhaps the Philippines might solve the problem for all. Provide a revenue stream, which will boost the sp as well as perk interest of a BP for BO, all imo.