Jake/Marc (or any other knowledgeable legal profes
Post# of 153847
(Total Views: 537)
Posted On: 09/29/2022 8:18:09 PM
Jake/Marc (or any other knowledgeable legal professional here) - can you put a best guess on the timeline and potential damages size for the Amarex lawsuit resolution (best, base, and worst case scenarios)?
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Other comments:
-I lean ohms way Re solid evidence will lift the veil. The warning letter closeout process was completed, website banner removed. I see no reason why the clinical hold wouldn't be lifted in due course w/ the appropriate data provided
-The company is turning from buckshot to laser guided - maximize return at the lowest cost (cost = time, risk, opportunities missed, etc.) as per a careful NPV analysis. This isn't akin to a message board poster putting their finger in the air and pointing in the direction the wind is blowing, this is risk-benefit analysis at its best.
-Rebranding of company...name change? CYrus no likey CYdy? "our external persona and corporate brand is going to evolve to align with our new strategy"
-No one commented on Kelly re: unmet medical need - hint hint - this our approval backdoor? --> "In people living with HIV, the rate of NAFLD is approximately 50% and the NASH rates are almost double the general population. Due to the underlying diagnosis of HIV, most of these patients are excluded from clinical trials for NASH, and this represents an unmet medical need."
-Board is solid - don't underestimate their network effect (Celgene/Regeneron, Gilead, etc...) and access to resources/guidance/backdoors
-Right to try - it's sophie's choice...I wouldn't be surprised at 500-1000 requests, at a minimum, per year on average. Believe it costs them 6-figures at a minimum to fulfill each re: raw materials, resources (time & manpower) used, followup required, etc. - your call...have the company come off as a bankrupt hero to a handful (& lose all your invested $$) or as a valued entity to millions for decades to come (with the price being the lives of the few)
Was a good start under strong new leadership if you ask me, next comes execution of the plan.
===========================
Other comments:
-I lean ohms way Re solid evidence will lift the veil. The warning letter closeout process was completed, website banner removed. I see no reason why the clinical hold wouldn't be lifted in due course w/ the appropriate data provided
-The company is turning from buckshot to laser guided - maximize return at the lowest cost (cost = time, risk, opportunities missed, etc.) as per a careful NPV analysis. This isn't akin to a message board poster putting their finger in the air and pointing in the direction the wind is blowing, this is risk-benefit analysis at its best.
-Rebranding of company...name change? CYrus no likey CYdy? "our external persona and corporate brand is going to evolve to align with our new strategy"
-No one commented on Kelly re: unmet medical need - hint hint - this our approval backdoor? --> "In people living with HIV, the rate of NAFLD is approximately 50% and the NASH rates are almost double the general population. Due to the underlying diagnosis of HIV, most of these patients are excluded from clinical trials for NASH, and this represents an unmet medical need."
-Board is solid - don't underestimate their network effect (Celgene/Regeneron, Gilead, etc...) and access to resources/guidance/backdoors
-Right to try - it's sophie's choice...I wouldn't be surprised at 500-1000 requests, at a minimum, per year on average. Believe it costs them 6-figures at a minimum to fulfill each re: raw materials, resources (time & manpower) used, followup required, etc. - your call...have the company come off as a bankrupt hero to a handful (& lose all your invested $$) or as a valued entity to millions for decades to come (with the price being the lives of the few)
Was a good start under strong new leadership if you ask me, next comes execution of the plan.
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