Don't worry about it. I have been watching US and Australian biotechs for much longer than is healthy for anyone!
I do get how HC is fun. I posted a fair bit up to about 2010. I keep getting lured back by a statement or something I see, every now and then, generally, that might hurt retailers. The 100% chance of approval post a positive panel meeting, posters were taking a JAMA article to mean, was one such instance. It went against my memory of things and a paper I had recently read.
What got me looking at HC, again, is that remestemcel-L's FDA approval will be HUGE for Australian biotech. From memory, we have never had an Autralian company get a therapeutic get past a panel, only ones that have been bought or licenced (CSL not included). Chemgenex was shot down (later it was acquired by Teva, who got omacetaxine to FDA approval), QRXPharma was shot down and Pharmaxis was shot down (we will know soon if Chiesi can get Bronchitol to the finish line this time. In 2013, the panel voted 0-14 and, in 2019, it voted 9:7 in favour). Biota, who licenced Relenza, to GSK before it to the FDA had a bumpy ride through. Finally, there was Peplin, whose igenol mebutate (later, branded Picato) received FDA approval in 2012, but Peplin was acquired by Leo Pharma in 2009 and it was Leo that finshed off the development work and gained the approval. Picato was a ble to bypass an advisory meeting. The FDA said in its approval letter, "your application for ingenol mebutate was not referred to an FDA advisory committee because outside expertise was not necessary; there were no controversial issues that would benefit from advisory committee discussion".
Melbourne not-for profit, Medicines Development for Global Health got the FDA’s approval of moxidectin, an oral treatment for river blindness (onchocerciasis) in 2018. That went straight through to FDA approval, as well, bypassing a committee meeting.
Can anyone think of any other Australian companies whose drug/biologic, either directly, after licencing or sale, went all the way to FDA approval or a Complete Response Letter?
No CSL examples. They've done it a lot.
Lastly, back on MSB,also, unmentioned, are things like the Lonza facility, which we don't know about, yet. Just the other week, the FDA batted down a drug from a company called Fennec. Not for problems with their drug, which was for chemotherapy-related hearing loss, but problems at the plant they had contracted to make it. Before anybody gets too fired up about this, I am not saying anything like Lonza will fail inspection. I am just adding colour to the whole process of FDA approval.
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