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Posted On: 11/06/2020 12:14:38 PM
Post# of 148908
Re: Boatbuilder #64487
It was here, in the article from business insider this morning. I misread the part about the PDUFA being two weeks away - two weeks from the official filing which hasn't been submitted yet. My apologies to anyone I misled. Here's the paragraph from Sandburg's article:
"The MHRA gave CytoDyn the green light to file their BLA but many investors have failed to grasp the sheer magnitude of this statement and what is behind it. The BLA is a couple hundred thousand page document. This isn’t something that is quickly changed in MS Word and then gets printed out because BLA’s could be up to 200,000 pages.
The good news is that CydoDyn had been working on a version for about 2 years before this meeting and it is essentially in the same format and acceptable to the UK. Dr Mahboob is on the team finalizing the BLA for submission. The company is also working to secure a UK distribution deal. After the BLA is submitted most investors fail to realize that the MHRA only takes about 2 weeks to review the package to get the USA equivalent of a PDUFA date."
"The MHRA gave CytoDyn the green light to file their BLA but many investors have failed to grasp the sheer magnitude of this statement and what is behind it. The BLA is a couple hundred thousand page document. This isn’t something that is quickly changed in MS Word and then gets printed out because BLA’s could be up to 200,000 pages.
The good news is that CydoDyn had been working on a version for about 2 years before this meeting and it is essentially in the same format and acceptable to the UK. Dr Mahboob is on the team finalizing the BLA for submission. The company is also working to secure a UK distribution deal. After the BLA is submitted most investors fail to realize that the MHRA only takes about 2 weeks to review the package to get the USA equivalent of a PDUFA date."
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