The FDA wants to put in place 'standards' that allow replication in the manufacturing process.
Having worked in the area of 'standards' in a previous (telco) life, I'm not worried at all.
To me, setting 'standards' in a completely new field of medicine is the FDA doing their job. The are pressure-testing the 'nuts and bolts' of the manufacturing process.
It's all part of the process.
IMO
Thanks Kervio. A good analysis and summary.
Efficacy is not an issue.
The FDA wants to put in place 'standards' that allow replication in the manufacturing process.
Having worked in the area of 'standards' in a previous (telco) life, I'm not worried at all.
To me, setting 'standards' in a completely new field of medicine is the FDA doing their job. The are pressure-testing the 'nuts and bolts' of the manufacturing process.
And I for one assume SI and LONZA are all over this.
Worry factor: "Next!"
All IMHO.
MSB Price at posting: $4.87 Sentiment: Buy Disclosure: Held
MSB Price at posting:
$3.89 Sentiment: Buy Disclosure: Held
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