RE: FDA.gov website6 May 2018 11:38
Elegance,
Some good points in your 16.58 post. There is no doubt that the FDA are keen to approve new, effective and safe lupus treatments. They've been working with lupus patient advocacy groups and are fully aware of the urgent need for such treatments.
However, not sure it's a good idea to raise expectations of marketing approval on the basis of this trial - results had to be unequivocal for that to be the case. The FDA are not going to approve on safety alone and the Lupuzor trial didn't reach statistical significance on efficacy. Best case scenario for P140 peptide in lupus IMO is that another trial will be needed in SLE and probably in much larger numbers of patients.
I believe that Sylviane Muller had some good preclinical data for P140 in other autoimmune and inflammatory diseases and who knows, perhaps that's the way forward? Or perhaps drilling down into the data will produce some results in sub groups of patients that may be worth exploring further and be enough to persuade someone to take Lupuzor on? So I can see there could be a bull case here but it shouldn't be based on FDA approval.
All just IMO of course.