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Posted On: 05/04/2021 10:16:55 AM
Post# of 148908
The announcement recently about re-applying for the Rolling Review for the HIV BLA because it expired has some bearing on this filing.
Last time we filed for BLA we had the possibility of the Rolling Review but didn’t take advantage of that direction of reviewing each part of the BLA in a section by section review as it was completed. We just filed the whole BLA at one time and had previously only filed the manufacturing section for review previous to the rest.
My understanding is we could of filed section by section and sought guidance as we went along. Being a fledgling biotech you would think that would of been the way of choice. To have the FDA evaluate each section as it is completed and correct those that are not properly formatted or missing the needed information.
I think Amerex had some bearing on completing the BLA and thought it was proper enough to file it all at one time. That didn’t work out and the advantage of rolling review wasn’t really used as it could of been.
The relationship between Amerex and Cytodyn didn’t suffer for this set back and we continue to use Amerex for our trial performance and oversight. Yet the new Merck employee specializes in Trials oversight amongst many skills this employee has. What does this say? The old saying... fool me once and shame on you. Fool me twice and shame on me. Comes to mind. My hope is we won’t be fooled again to believe we have this completed when it’s not approvable.
There were only two parts of the BLA we needed to correct and now we have apparently corrected those two parts or are very close to completing those corrections.
Does rolling review mean that we can submit those corrected issues for review without full filing and have the blessing of the correction first before completing the whole BLA submission? I am not completely sure on what flexibility is given to rolling review but it seems likely that is the way a rolling review should work. Perhaps someone has the knowledge of section by section rolling review and if we need to file again by section or just complete the corrections to the sections we didn’t meet the grade? The filing could be very quick with just a couple corrections for rolling review and then submit the whole BLA right after we complete that correction review.
I want to believe it is that easy. That we can ask for corrections to be reviewed before seeking approval for the whole BLA to avoid another Refusal to File Letter. Another RFL would be devastating. So rolling review might be the action of choice if it works for seeking correction advice before complete submission for approval. Let’s hope that is the way it works because we had a completed BLA with two problems already now corrected or at least by July they will be completely corrected.
Last time we filed for BLA we had the possibility of the Rolling Review but didn’t take advantage of that direction of reviewing each part of the BLA in a section by section review as it was completed. We just filed the whole BLA at one time and had previously only filed the manufacturing section for review previous to the rest.
My understanding is we could of filed section by section and sought guidance as we went along. Being a fledgling biotech you would think that would of been the way of choice. To have the FDA evaluate each section as it is completed and correct those that are not properly formatted or missing the needed information.
I think Amerex had some bearing on completing the BLA and thought it was proper enough to file it all at one time. That didn’t work out and the advantage of rolling review wasn’t really used as it could of been.
The relationship between Amerex and Cytodyn didn’t suffer for this set back and we continue to use Amerex for our trial performance and oversight. Yet the new Merck employee specializes in Trials oversight amongst many skills this employee has. What does this say? The old saying... fool me once and shame on you. Fool me twice and shame on me. Comes to mind. My hope is we won’t be fooled again to believe we have this completed when it’s not approvable.
There were only two parts of the BLA we needed to correct and now we have apparently corrected those two parts or are very close to completing those corrections.
Does rolling review mean that we can submit those corrected issues for review without full filing and have the blessing of the correction first before completing the whole BLA submission? I am not completely sure on what flexibility is given to rolling review but it seems likely that is the way a rolling review should work. Perhaps someone has the knowledge of section by section rolling review and if we need to file again by section or just complete the corrections to the sections we didn’t meet the grade? The filing could be very quick with just a couple corrections for rolling review and then submit the whole BLA right after we complete that correction review.
I want to believe it is that easy. That we can ask for corrections to be reviewed before seeking approval for the whole BLA to avoid another Refusal to File Letter. Another RFL would be devastating. So rolling review might be the action of choice if it works for seeking correction advice before complete submission for approval. Let’s hope that is the way it works because we had a completed BLA with two problems already now corrected or at least by July they will be completely corrected.
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