The Edison report is a nice read.
http://www.edisoninvestmentresearch.com/?ACT=18&ID=18566&LANG=
I especially like the part on page 7 regarding a potential accelerated approval. It would be sensational to have the Cavatak/Yervoy combo in the clinic saving lives, in the near future potentially, if the trial continues to generate excellent results....
"Potential for an accelerated approval application if circumstances are right
Viralytics has pointed out that the expanded MITCI trial could put it on the path to undertake a pivotal study of Cavatak plus Yervoy in melanoma patients who have failed treatment with PD1/L1 therapies. However, we believe that under certain circumstances the MITCI data could also be used to support an application for accelerated approval in the US. This would depend on continued high response rates in the additional 44 patients (preferably together with continued low adverse events rates) and there continuing to be a significant unmet need for an effective treatment for this patient group (in this regard Amgen’s Imlygic/Yervoy combo trial (NCT01740297) will be an important one to watch).
We note that the FDA approved Bavencio (avelumab) for metastatic Merkel cell carcinoma in March 2017 based on a 33% response rate in an 88-patient, single-arm trial. This data set is not much larger than the one Viralytics will have at the completion of the enlarged MITCI study. "
GLTAH.
