CytoDyn Investors Sell Despite Positive Recommendation From DSMB And A More Certain Path To COVID-19 Approval
By Moon Kil Woong
Tuesday, October 20, 2020 2:35 PM EDT
"Leronlimab is clearly the front runner as the next therapeutic for COVID-19 and their challengers will have a high bar to cross because few if any are using mortality as an endpoint.
" By adding a 42-day survival rate they are giving the company another means by which to seek approval. It appears that in the data the DSMB saw a very favorable trend.
"By adding a 42-day survival rate they are giving the company another means by which to seek approval. It appears that in the data the DSMB saw a very favorable trend.
"..softness in the patient recruitment numbers..with the conference call approaching in hours investors have to consider that they may have a plan to add additional sites. They currently have 15 clinical trial sites recruiting and added one within the past month. The United Kingdom's clinical sites have not come online
"Now that the DSMB has rendered its recommendations, the company will take these recommendations to the FDA and figure out a path forward.
"MHRA from the United Kingdom was waiting for this interim data point and it is clearly positive in a sea of therapeutic failures.. Just recently vaccines and therapeutics have been placed on hold or paused for safety. Gilead Sciences (GILD) remdesivir also got denounced by the World Health Organization..MHRA was waiting for the interim readout to make a decision on how to proceed with their version of emergency use approval.
"The best news of all is that the DSMB pretty much assured the company that their trial was on target and likely to reach their endpoint of mortality benefit. CytoDyn has a clear pathway to approval unlike any other drug.
"The company could make a very strong case for an EUA and it's reasonable to suspect that they will, but what investors have learned is that CytoDyn will ask the FDA for their opinion on whether or not they should file the EUA. So if they do announce a filing of an EUA this go around it is likely that they received positive input from the FDA.
By Moon Kil Woong
Tuesday, October 20, 2020 2:35 PM EDT
"Leronlimab is clearly the front runner as the next therapeutic for COVID-19 and their challengers will have a high bar to cross because few if any are using mortality as an endpoint.
" By adding a 42-day survival rate they are giving the company another means by which to seek approval. It appears that in the data the DSMB saw a very favorable trend.
"By adding a 42-day survival rate they are giving the company another means by which to seek approval. It appears that in the data the DSMB saw a very favorable trend.
"..softness in the patient recruitment numbers..with the conference call approaching in hours investors have to consider that they may have a plan to add additional sites. They currently have 15 clinical trial sites recruiting and added one within the past month. The United Kingdom's clinical sites have not come online
"Now that the DSMB has rendered its recommendations, the company will take these recommendations to the FDA and figure out a path forward.
"MHRA from the United Kingdom was waiting for this interim data point and it is clearly positive in a sea of therapeutic failures.. Just recently vaccines and therapeutics have been placed on hold or paused for safety. Gilead Sciences (GILD) remdesivir also got denounced by the World Health Organization..MHRA was waiting for the interim readout to make a decision on how to proceed with their version of emergency use approval.
"The best news of all is that the DSMB pretty much assured the company that their trial was on target and likely to reach their endpoint of mortality benefit. CytoDyn has a clear pathway to approval unlike any other drug.
"The company could make a very strong case for an EUA and it's reasonable to suspect that they will, but what investors have learned is that CytoDyn will ask the FDA for their opinion on whether or not they should file the EUA. So if they do announce a filing of an EUA this go around it is likely that they received positive input from the FDA.
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