From YMB Been meaning to share my perspective for a long time on this board, and now here goes.
As background: I am relatively new to investing, and have been working with FDA as a regulatory professional representing small biotechs for over 10 years. I have worked on multiple new COVID drugs in the past six months.
I agree with the sentiment expressed by cool heads on this board that there is too much pressure for things to happen quickly. In my experience, the best way to succeed with FDA (and other regulatory bodies) is to approach them openly and transparently, and not to DEMAND approval but to COLLABORATE on approval. My impression is that Cytodyn is doing this now, by asking FDA and MHRA for their opinion on the currently available data. Based on my experience, I believe the interest in the severe/critical study readout from both agencies is very a strong signal of their intention to act quickly if results are positive.
Another point I think is very important for Cytodyn in the COVID game, which many others have expressed, is that APPROVAL is different than AUTHORIZATION. Approval is a much, much better goal and worth waiting for. I too have been frustrated by the EUA for remdesivir, but as a huge company they have the resources to enroll many thousands of patients to reach for statistical significance with a tiny effect size. The fact that any effect was visible in the small M/M trial with Leronlimab is promising. It is my opinion that the willingness of FDA to COLLABORATE on a Phase III study for the moderate population speaks to their intent to APPROVE the drug for this population, if endpoints are met.
The bottom line is that the COVID application could absolutely still fail. I think it is very unlikely, especially after hearing the physicians on the call yesterday, but anecdotal data is just that - anecdotal. Until the S/C readout is available, patience will be the only investment strategy that is rewarded with this stock. However, the science here is strong, and the observation that patients recovered from ARDS/sepsis/other severe conditions when administered Leronlimab (and decrease in key cytokines was concurrent) is convincing enough for me.
As for the HIV BLA - I think the company has certainly had missteps along the way with the application process. I also know from experience that FDA does not grant fast track status easily. They are intentional in their selection of drugs for this designation, and Leronlimab has clearly met the bar. I think an approval for HIV could come in 6-8 months (normally 10-12 months from filing) with an 'accelerated' PDUFA date, depending on how much data has been officially 'submitted' using the rolling review process. If this happens sooner, I will be pleasantly surprised, and if not, I will wait patiently.
There is still the specter of competition, and there are many good resources to see where other drugs are in the competitive landscape. One of my favorites is updated regularly by a professional organization for regulatory affairs: https://www.raps.org/news-and-articles/news-a...cs-tracker. The most interesting, in my opinion, are Lenzilumab and Aviptadil (particularly the inhaled version). I do not own any shares of HGEN nor do I plan to, but I think they are the most significant competitor here as they are in Phase III and seem to be making significant progress with a similar-ish MoA (reduction of cytokines). As for Aviptadil/RLFTF, I do own shares and still think it is very promising, although their shareholder-facing presence has been significantly more reserved (which I tend to see as a positive) so I don't have much certainty about their progress. They may surprise everyone with a big announcement, but the inhaled version is what I find most promising from a scientific perspective, and it appears that trial is still in early stages.
I want to emphasize that, for the sake of humanity and especially the united states, I won't be disappointed if competitors 'beat us to the finish line' because it means hundreds of thousands of lives may be saved. I will simply hold for the HIV approval and take profits at that point.
However, I do think that things could quickly escalate for Cytodyn if results from the S/C are positive. This is not a new revelation for many on this board, but worth restating that at this point, those results appear to be the next significant catalyst.
I look forward to thoughtful comments/questions.
As background: I am relatively new to investing, and have been working with FDA as a regulatory professional representing small biotechs for over 10 years. I have worked on multiple new COVID drugs in the past six months.
I agree with the sentiment expressed by cool heads on this board that there is too much pressure for things to happen quickly. In my experience, the best way to succeed with FDA (and other regulatory bodies) is to approach them openly and transparently, and not to DEMAND approval but to COLLABORATE on approval. My impression is that Cytodyn is doing this now, by asking FDA and MHRA for their opinion on the currently available data. Based on my experience, I believe the interest in the severe/critical study readout from both agencies is very a strong signal of their intention to act quickly if results are positive.
Another point I think is very important for Cytodyn in the COVID game, which many others have expressed, is that APPROVAL is different than AUTHORIZATION. Approval is a much, much better goal and worth waiting for. I too have been frustrated by the EUA for remdesivir, but as a huge company they have the resources to enroll many thousands of patients to reach for statistical significance with a tiny effect size. The fact that any effect was visible in the small M/M trial with Leronlimab is promising. It is my opinion that the willingness of FDA to COLLABORATE on a Phase III study for the moderate population speaks to their intent to APPROVE the drug for this population, if endpoints are met.
The bottom line is that the COVID application could absolutely still fail. I think it is very unlikely, especially after hearing the physicians on the call yesterday, but anecdotal data is just that - anecdotal. Until the S/C readout is available, patience will be the only investment strategy that is rewarded with this stock. However, the science here is strong, and the observation that patients recovered from ARDS/sepsis/other severe conditions when administered Leronlimab (and decrease in key cytokines was concurrent) is convincing enough for me.
As for the HIV BLA - I think the company has certainly had missteps along the way with the application process. I also know from experience that FDA does not grant fast track status easily. They are intentional in their selection of drugs for this designation, and Leronlimab has clearly met the bar. I think an approval for HIV could come in 6-8 months (normally 10-12 months from filing) with an 'accelerated' PDUFA date, depending on how much data has been officially 'submitted' using the rolling review process. If this happens sooner, I will be pleasantly surprised, and if not, I will wait patiently.
There is still the specter of competition, and there are many good resources to see where other drugs are in the competitive landscape. One of my favorites is updated regularly by a professional organization for regulatory affairs: https://www.raps.org/news-and-articles/news-a...cs-tracker. The most interesting, in my opinion, are Lenzilumab and Aviptadil (particularly the inhaled version). I do not own any shares of HGEN nor do I plan to, but I think they are the most significant competitor here as they are in Phase III and seem to be making significant progress with a similar-ish MoA (reduction of cytokines). As for Aviptadil/RLFTF, I do own shares and still think it is very promising, although their shareholder-facing presence has been significantly more reserved (which I tend to see as a positive) so I don't have much certainty about their progress. They may surprise everyone with a big announcement, but the inhaled version is what I find most promising from a scientific perspective, and it appears that trial is still in early stages.
I want to emphasize that, for the sake of humanity and especially the united states, I won't be disappointed if competitors 'beat us to the finish line' because it means hundreds of thousands of lives may be saved. I will simply hold for the HIV approval and take profits at that point.
However, I do think that things could quickly escalate for Cytodyn if results from the S/C are positive. This is not a new revelation for many on this board, but worth restating that at this point, those results appear to be the next significant catalyst.
I look forward to thoughtful comments/questions.
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