Below is an update from my BIL. Can anyone help w
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Posted On: 09/13/2021 10:49:09 AM
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Below is an update from my BIL. Can anyone help with the Patent issue?
Hopefully they can fix these wrongs and get the Brazil trials nailed. Things are at least going in the right direction now!!
NJ
I talked with a few colleagues this week about leronlimab. Here are their thoughts:
- agreed that the data from the 30 pts with TNBC in the Ph1b/2 study is impressive
- concerned that Cytodyn has not yet moved into a Ph 2 or 3 study with the drug. Typically, a company would capitalize on this type of data release by swiftly moving into next stage of development
- The company apparently made some development mistakes with the drug in a study of COVID-19 patients and received highly unusual, public admonishment from FDA about the study design and data from the company’s study that was submitted to FDA. While not directly connected to TNBC development, it does not bode well that the company ignored the FDA’s comments about appropriate design of the COVID study
- as you may have seen in other press releases, there is an active Cytodyn investor group, pushing for changes on the board and executive team. Unsure what this means, but a displeased and vocal investor group is typically associated with management mistakes and/or wrongdoing.
- it’s not clear, based on publicity available info, what the patent situation is with the drug. As the drug has been in development for many years, there may be minimal residual patent life, if the drug is ever approved for use.
Hopefully they can fix these wrongs and get the Brazil trials nailed. Things are at least going in the right direction now!!
NJ
I talked with a few colleagues this week about leronlimab. Here are their thoughts:
- agreed that the data from the 30 pts with TNBC in the Ph1b/2 study is impressive
- concerned that Cytodyn has not yet moved into a Ph 2 or 3 study with the drug. Typically, a company would capitalize on this type of data release by swiftly moving into next stage of development
- The company apparently made some development mistakes with the drug in a study of COVID-19 patients and received highly unusual, public admonishment from FDA about the study design and data from the company’s study that was submitted to FDA. While not directly connected to TNBC development, it does not bode well that the company ignored the FDA’s comments about appropriate design of the COVID study
- as you may have seen in other press releases, there is an active Cytodyn investor group, pushing for changes on the board and executive team. Unsure what this means, but a displeased and vocal investor group is typically associated with management mistakes and/or wrongdoing.
- it’s not clear, based on publicity available info, what the patent situation is with the drug. As the drug has been in development for many years, there may be minimal residual patent life, if the drug is ever approved for use.
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