The palpable excitement of Dr. Kasi, Dr. Jay, and now Reny Aniline of Natera was certainly a highlight. Reny said he'd never seen any ctDNA response to an msCRC drug like this. Nice that Reny was amazed to see the graphic results where the reduction brought about in virtually the entire Leron arm was greater than the median of the backbone combo. Glad to hear Jay very confident that we'll blow away SUNLIGHT's results. I had heard that three patients were doing so well that they left the program to get (hopefully) curative surgery. But this was the first time I had heard anything about the first two patients in the Rollover arm of the CLOVER trial, who after a year of progressing got an ICI to go along w 700 mg of Leron, and the early results were, as Jay said cautiously, "promising." That lifted my heart. I was also glad to see the clear demarcation between 350 mg and 700 mg doses of Leron in ctDNA; the former had a median of 80% reduction, the latter 90%. So I hope, given the perfect safety results, we've seen the last of the 350 mg trials. 700 worked better, and in fact it worked great.
I know Misiu will be glad that Jay is going back to the scientific side, but I find Jay a better presenter than Robert Hoffman, and I hope the latter's financial expertise will help us more at CEO.
Apparently Jay hasn't met with the FDA yet and so he doesn't know if BTD, Fast Track, or the path toward Accelerated Approval will be chosen. This was my greatest disappointment with the call, but timing always runs slower than we hope or think.
Very little of the presentation had much to do with anything beyond CLOVER, but at least the range of activities, oncological and beyond, is impressive. Sounds like the ISPY trials in both CRC and TNBC will be launching any minute.
Oh, forgot to mention that two of the first 12 patients in the Alzheimer's trial requested to continue on the drug after the trial because of their perceived sense of improvement -- no data yet, but man that's a great start!
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