The 48 week data is the final validation before the phase 3 trial is initiated I believe. Based on everything I have read, this data should be as good or better than the 24 week data. This drug has been used safely and effectively for thousands of patients for other indications. No reason to think that it will be rejected due to safety concerns for lupus nephritis. Only a matter of proving greater efficacy than the SOC which it already has at 24 weeks. The arduous process to get this drug approved is a great example of why the FDA needs to be reformed. In this case, the drug was already proven to be safe for other indications and its 24 week data was excellent and should have been sufficient to enter phase 3 at that point. What an enormous waste of time and money. No wonder drugs cost a ridiculous amount; how else could biopharmas take the enormous monetary risk without the possibility of recuperating their expenses upon approval.
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