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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: allatwwk who wrote (50225)	2/9/2019 4:42:03 AM
From: kdd999	1 Recommendation Recommended By EMU2 Respond to of 63276

Remember, AA is for any drug, not just MABs or other biologics. Some of those are much easier to manufacture, so they would have much less problem with manufacturing readiness. I still don't know where they got the 38/38. We really want to know, for all AA applications for biologics, how manywent on and received AA. For 2015, considering BLAs only, not all the other drugs on earth, there were 7 Priority approvals, 5 of which were also orphan drug. Priority means AA, BTD, fast track, or some combo thereof. For 2016, there were 3 total, 1 was also orphan drug. For 2017, there were 9 total, 4 priority only, 5 also orphan drug. So 2015-2017, if all priority approvals were AA (but they weren't), we would have 19 approvals, 11 for orphan drugs. The following report goes from 1991 to June 30 2018, and lists all BLA and supplemental BLA approvals: fda.gov. I counted 20 BLA's and 25 supplemental BLAs, mostly for MABs. In looking at the table, most of those early approvals were 4 or 5 months, and this was way before AA. Of course, the early ones were all for big companies. This is all BLA's, not just priority. And Supplemental is not same as original BLA. I am still looking for total BLA # for the denominator. It is even harder to get the denominator. They list total AA applications by year, but they don't divide into BLA and NDA. Also, you can't match up because the approvals list the drug and dates, but the applications do not list the drugs or the application date, so you cannot match up the same applicant with its approval. I'm looking for the link to this table, I can't find it again right now, their site is so hard to navigate. I will update when I get a BLA application list.