agree - would be nice to have a clear path forward
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Posted On: 09/30/2020 6:12:56 PM
agree - would be nice to have a clear path forward as that's all that matters. The story to my ears changes every time I hear NP speak. It's now at the point I just don't believe in anything he says and instead use the data we do have. If you look at the past, and you look at the recent - in my mind I have the following expectations:
6 months to 9 months for BLA (and if its sooner, great).
6 months to 9 months for COVID EUA somewhere (again sooner, great would love to be wrong on this one) - don't end the S/C early if we can - the more data and higher numbers we have the better. It will actually shorten the process with the FDA - it will make it easier for them to feel comfortable with a decision in our favor. In fact, we need more data (ie. say 1000 to 3000 Moderates also). More data, faster = a) save lives b) restore the economy of the world. EUA will also get lots of data once in action. That will give BLA faster.
Both these are big opportunities - 6 months may seem like forever - but it isn't. We are unfortunately only starting with COVID. Winter is coming to the USA, and this still has the risk of being exponential (again I hope not) in growth. We have a long way to go - about 100MM to 150MM people in the USA at least with a good contagion strategy before we exit the other side. Thats huge numbers.
For HIV - we have a solid product.
we just now need to be realistic on timelines and the level of data needed to get approvals. We need to be honest about it and do trials with realistic numbers and goals in mind.
A the moment, it feels like the trials are structured as tools for raising capital. Hence the need for many indications and small trials to back up those claims with potential investors. Maybe thats what we have to do, maybe not. But 25M shares sold to invest now in COVID trials and cancer at $3 to $4 would have raised a lot of money to speed that up.
NOTE :
I also hold NP accountable - its his job to get the submission right. I wander how much is a team that hasn't done it before.
From his own words (and remember this is a non medical person) , he claims his role is to :
"Dr. Pourhassan has overseen the rapid preclinical and clinical developments of leronlimab (PRO 140) as a therapy for HIV, from Phase 2 development into successful completion of Phase 3 trials. This includes the oversight of the development of trial protocols and interaction with the U.S. Food and Drug Administration (FDA).'
6 months to 9 months for BLA (and if its sooner, great).
6 months to 9 months for COVID EUA somewhere (again sooner, great would love to be wrong on this one) - don't end the S/C early if we can - the more data and higher numbers we have the better. It will actually shorten the process with the FDA - it will make it easier for them to feel comfortable with a decision in our favor. In fact, we need more data (ie. say 1000 to 3000 Moderates also). More data, faster = a) save lives b) restore the economy of the world. EUA will also get lots of data once in action. That will give BLA faster.
Both these are big opportunities - 6 months may seem like forever - but it isn't. We are unfortunately only starting with COVID. Winter is coming to the USA, and this still has the risk of being exponential (again I hope not) in growth. We have a long way to go - about 100MM to 150MM people in the USA at least with a good contagion strategy before we exit the other side. Thats huge numbers.
For HIV - we have a solid product.
we just now need to be realistic on timelines and the level of data needed to get approvals. We need to be honest about it and do trials with realistic numbers and goals in mind.
A the moment, it feels like the trials are structured as tools for raising capital. Hence the need for many indications and small trials to back up those claims with potential investors. Maybe thats what we have to do, maybe not. But 25M shares sold to invest now in COVID trials and cancer at $3 to $4 would have raised a lot of money to speed that up.
NOTE :
I also hold NP accountable - its his job to get the submission right. I wander how much is a team that hasn't done it before.
From his own words (and remember this is a non medical person) , he claims his role is to :
"Dr. Pourhassan has overseen the rapid preclinical and clinical developments of leronlimab (PRO 140) as a therapy for HIV, from Phase 2 development into successful completion of Phase 3 trials. This includes the oversight of the development of trial protocols and interaction with the U.S. Food and Drug Administration (FDA).'
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