Most of the time hard to find ... BUT .... a good Yahoo post "hindustunna" posted this Sunday. sburns4744 was kind enough to point it out to me since I had not sifted through the garbage heap over there for a couple of days. The post (below) is one of the responses on this topic:
http://finance.yahoo.com/mbview/threadview/?&bn=18a6f803-b524-3418-872e-40aca987971a&tid=1400984199855-806dfefc-bf7c-4a8f-bb3f-67024ffa0e68
" hindustunna • May 25, 2014 2:54 PM
10 users liked this posts 1 users disliked this posts
Medium-term lurker here, 1st time poster. I'm an oncologist, but I haven't worked on any of the PV-10 studies. Feel the need to post now because I get the sense that most of the posters are misreading the FDA letter and what they're actually trying to say.
The FDA letter is NOT bipolar or contradictory. There is no disagreement among anyone (FDA, shareholders, mgt, oncologists) about substantial tumor and bystander response to PV-10 injections, hence the FDA acknowledgement of "reduction in the size of one to 10 target lesions...".
In fact, the FDA explains exactly what they meant by "the preliminary clinical data do not demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints" in the very next sentence of the letter (which unfortunately never seems to be quoted): "This determination is based on the paucity of data on endpoints indicative of clinical benefit (e.g., pain, infection, significant bleeding)".
I.e. the FDA is saying that the application did not have sufficient data on pain, infection, bleeding in response to PV-10 injections to demonstrate a clinically (i.e. statistically) significant response. In hindsight, this is fairly obvious since this data would've had to be collected at multiple time points during the Phase 2 study, and nobody involved was thinking about symptom control as the approval pathway at that time.
Basically, the FDA is saying that PVCT hasn't collected enough data to demonstrate "symptom relief", which is the indication they are applying for. Tumor shrinkage, bystander response, etc. does not equal symptom relief. Any bridging study or PIII study would need to prospectively measure symptom scores with objective, validated metrics and demonstrate a significant decrease after PV-10 injection, and show that this decrease is durable over a reasonable follow-up period. This type of study should be relatively short and simple to complete, and the FDA still is not requesting survival data." |
