From Seeking Alpha (this is well written and IMO the most likely outcome):
prashant.krishnan
Comments (1)
17 Oct. 2020, 2:01 PM
I believe that the real communication is in this statement. "Including a potential regulatory path forward". The regular regulatory path forward is to continue the trial for the 390 patients, if the interiem data is only approaching statistical significance and needs additional patients to reach statistical significance. This timeline will take us to January-February 2021, when the company may communicate to FDA on EUA/BLA.
The potential regulatory path forward, means something that can potentially shorten this timeline to FDA approval. Which basically means that statistically speaking the interium data has already produced a statistically significant P value compared to standard of care.
The DSMC has the power only to recomend. Only the sponser (the company) can decide whether to continue, change end points or apply for an EUA or any combination of that.
At this point i believe that the DSMC has recomended, the company apply for an EUA (potential regulatory pathway), and that they will positively back the company as a third party with the FDA. The company on the other hand is going to weigh the option of A. Applying for an EUA, while continuing the trial after taking a statistical penalty, or B. Apply for EUA/BLA parallelly and stop the trial completely, because of overwhelming benifit.
These two options present different timelines for full approval and different regulatory risks.
It's an option or choice they have to make because, to do option A, they have to unblind the data and take a statistical penalty, which in this case, may mean increasing the size of the trial, which will take the companys BLA on covid timeline beyond the regular timeline, probably Next March to March 2021. They may have to take a statistical penalty in addition to applying for EUA to reduce the risk on the BLA while applying with FDA for a full approval. If they take option B, Even if the company gets an EUA, they may risk a full approval, if FDA after looking into the data, recomends adding a new cohort to the trial.
I think the presentation the company will make is to present investors these options that the company has and what the management has decided to be the best path forward, given the financial and regulatory risks.
prashant.krishnan
Comments (1)
17 Oct. 2020, 2:01 PM
I believe that the real communication is in this statement. "Including a potential regulatory path forward". The regular regulatory path forward is to continue the trial for the 390 patients, if the interiem data is only approaching statistical significance and needs additional patients to reach statistical significance. This timeline will take us to January-February 2021, when the company may communicate to FDA on EUA/BLA.
The potential regulatory path forward, means something that can potentially shorten this timeline to FDA approval. Which basically means that statistically speaking the interium data has already produced a statistically significant P value compared to standard of care.
The DSMC has the power only to recomend. Only the sponser (the company) can decide whether to continue, change end points or apply for an EUA or any combination of that.
At this point i believe that the DSMC has recomended, the company apply for an EUA (potential regulatory pathway), and that they will positively back the company as a third party with the FDA. The company on the other hand is going to weigh the option of A. Applying for an EUA, while continuing the trial after taking a statistical penalty, or B. Apply for EUA/BLA parallelly and stop the trial completely, because of overwhelming benifit.
These two options present different timelines for full approval and different regulatory risks.
It's an option or choice they have to make because, to do option A, they have to unblind the data and take a statistical penalty, which in this case, may mean increasing the size of the trial, which will take the companys BLA on covid timeline beyond the regular timeline, probably Next March to March 2021. They may have to take a statistical penalty in addition to applying for EUA to reduce the risk on the BLA while applying with FDA for a full approval. If they take option B, Even if the company gets an EUA, they may risk a full approval, if FDA after looking into the data, recomends adding a new cohort to the trial.
I think the presentation the company will make is to present investors these options that the company has and what the management has decided to be the best path forward, given the financial and regulatory risks.
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