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Replies to #88212 on Biotech Values

iwfal

12/27/09 9:51 PM

#88234 RE: upndown1313 #88212

NVLT

Some modelling here suggests MOS at about 15 months based on study termination in January which would make it superior to Avastin. I can send you the link for your review if interested.



I doubt it since my model, bounded by an assumption of an X^2 enrollment curve and a linear enrollment curve, gives 12 to 14 months in early Feb. I don't think I've ever seen trial enroll later than x^2, nor earlier than x.

As for some general commentary on NVLT, I'll put together a comprehensive post sometime in the next day or two, but in the meantime I'll leave you with three comments:

1) NVLT has at least 160m fully diluted shares - my guess is >200m on a fully-diluted-after-successful-binary. So that will be a huge drag on any appreciation.

2) The company continually references that the trail is running long because their own chart shows that median survival in first line nsclc patients in the last decade is 10 months. But this completely ignores the change in treatment protocol for second and third line over the last decade. My guess is that the placebo group for the US/European patients will be above 11 months.

3) The company presentations tout the ORR in a US ph ii - 69% vs ~30% for placebo. And elsewhere in the same presentation they provide a chart of nsclc survival times and ORR for various trials (showing an ORR of between 25 and 40% - from memory). Ostensibly this chart is about the survival, but it nonetheless begs the comparison - but ignores the fact that the NOV-002 ORR is 50% response, not RECIST. The reality is that the ORR in NOV-002 arm (69%) is somewhat above historicals, but not hugely so. For a trial so small it is undoubtedly not even close to stat sig.