Misiu, ClosetInvestor, Schlingel, I think we a
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Posted On: 01/20/2020 2:19:22 PM
Misiu, ClosetInvestor, Schlingel,
I think we all have more or less the same objective, however, bear in mind that currently we are not pursuing several trials (or pre-trials) due to lack of funds !!. Of course, BLA is priority and I assume is already taken care of.
For example: would be to launch the pivotal trial for Mono. Do we have the funds ?? The answer, I think, is no. This is my priority number one as, once approved, will give us a steady and important revenue that will free our hands to go for the “jugular” of the other indications (apart from appreciating the stock considerably.).
It is quite possible that Combo and off-label can rovide semdecent funding but not sure if this will be enough to pursue the many venues we have ahead (we are victims of our own success)
The basket trial will be expensive (due to the number of potential indications). Remember, we need to follow up on EACH one very carefully and under controlled environment. The fact that is basket does not mean it is less stringent from the clinical perspective. It means we will have many more patients, quicker acceptance in the scientific/medical community, but much more planning and supervision needed. We don’t know if Lero works the same in all conditions, if not, we need to find why and so on … With the resources we have now we might be better concentrating in few conditions.
“Normally these trials are multi-year. The best, in my opinion is either license Leronlimab to BP for a front payment plus good royalties (The NASH market is estimated to reach between $20 billion to $35 billion), or, simply, partner with BP or Mid-Size Pharma and start trials (more money at the end but longest wait). CYDY does not have the resources to tackle on our own NASH (trials cost will be in the hundred's of millions), however more trials in large animals will drive the point to BP that we cannot be ignored. Need to continue with larger animal studies.
Also, PrEP market is large and we could tap some serious money. Fortunately we are advancing on this in two fronts (Thailand + USA)
I believe that at this stage I prefer any money being spent is clinical trials/research rather that in paying note-holders. Having said that they can't sell very rapidly ($equivalent of $350K/month) and, at some stage, we will have the money to absorb the notes without affecting the stock price .
I think we all have more or less the same objective, however, bear in mind that currently we are not pursuing several trials (or pre-trials) due to lack of funds !!. Of course, BLA is priority and I assume is already taken care of.
For example: would be to launch the pivotal trial for Mono. Do we have the funds ?? The answer, I think, is no. This is my priority number one as, once approved, will give us a steady and important revenue that will free our hands to go for the “jugular” of the other indications (apart from appreciating the stock considerably.).
It is quite possible that Combo and off-label can rovide semdecent funding but not sure if this will be enough to pursue the many venues we have ahead (we are victims of our own success)
The basket trial will be expensive (due to the number of potential indications). Remember, we need to follow up on EACH one very carefully and under controlled environment. The fact that is basket does not mean it is less stringent from the clinical perspective. It means we will have many more patients, quicker acceptance in the scientific/medical community, but much more planning and supervision needed. We don’t know if Lero works the same in all conditions, if not, we need to find why and so on … With the resources we have now we might be better concentrating in few conditions.
Quote:Indeed, and there are several companies working for some years on this. For example, Intercept Pharmaceuticals, Genfit (GNFTF), and Madrigal Pharmaceuticals (MDGL) are all exploring their own products as single therapies. Pfizer and Novartis are trying by targeting several pathways at once.
Nash is the only indication, which I would like to see partnered. The trials are just too long and expensive I believe. We should use that funds for other things.
Quote:
How would the next steps in a Nash trial look like, TechGuru, and what would it cost?
“Normally these trials are multi-year. The best, in my opinion is either license Leronlimab to BP for a front payment plus good royalties (The NASH market is estimated to reach between $20 billion to $35 billion), or, simply, partner with BP or Mid-Size Pharma and start trials (more money at the end but longest wait). CYDY does not have the resources to tackle on our own NASH (trials cost will be in the hundred's of millions), however more trials in large animals will drive the point to BP that we cannot be ignored. Need to continue with larger animal studies.
Quote:Yes, you are right !!!. And, again, we should be going faster with this. Why we are not doing it?? Funding.
GvHD is a low hanging fruit and CYDY needs to get after it. That’s my #3.
Also, PrEP market is large and we could tap some serious money. Fortunately we are advancing on this in two fronts (Thailand + USA)
Quote:
In regards to paying the note holder, I agree with cash instead of shares. But how much of a monthly burn would that be?
I believe that at this stage I prefer any money being spent is clinical trials/research rather that in paying note-holders. Having said that they can't sell very rapidly ($equivalent of $350K/month) and, at some stage, we will have the money to absorb the notes without affecting the stock price .
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