Provention Bio, Inc. (PRVB)

[sokol]

Yes, I agree. This is definitely something that may be cured. Receiving a CRL from the FDA is not good news, but the impact varies. In this case, the company may in the next few months produce the additional data from a study with multiple doses (as opposed to the single dose cited here) and a higher dose (as opposed to the lower dose also cited here). Lastly, the FDA in the … “CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted to the BLA and confirmed the acceptability of the proposed proprietary name for teplizumab.”