A human short would have recognized how volatile ITMN is from the action last Spring, and gotten out to await developments when the EU recommendation was published. Our basher (and I'm guessing that there's only one) seems to be informed enough to have seen the landscape. It doesn't make sense for him [her] to be short.
Yes, you are spewing BS. How many of the hysterical short posters on this board are you? All of them?
I've been trying to figure out a motivation for the slime puddle[s?] posting the negative lies. My best guess right now is that they're shills for some other stock market discussion board, trying to fill this one with so much pus and phlegm that it becomes unusable for humans.
My point was that the pirfenidone treated patients appeared to survive as long or longer than placebo in all the phase III trials - a trend consistent with the phase iI trial in Japan.
It remains to be seen if the Shionogi data is unusable in the US NDA filing. Would it be tough to convert the data set into something FDA will accept? You betcha. Could it be done?
How would you define a "real" phase III? 5,000 patients? Survival endpoint only?
The academic co-investigators involved in the ITMN studies were among the best in this field. Absolutely ITMN needs to have FDA on board for the study endpoints, but that doesn't necessarily mean FDA's position is fixed for all eternity.
"The overall data from both the ITMN and Shionogi phase III trials all seem to suggest that this drug increases survival."
This is BS. The Shionogi PIII data is unusable (ask the FDA) and the FDA also decided the ITMN data did not meet their endpoints.
It FAILED PIII and has to go through a "real" PIII this time. We will see in 2+ years if the drug is beneficial.
I understand your concern, however the clinical and pre-clinical data are a long way from associating this drug directly with cancer causation.
The bottom line for IPF patients is that they have a 3-5 year window of survival, a time frame that is up with some aggressive forms of cancer.
With regard to genotoxicity and the domino effect. Benzopyrenes, the product of combustion, are known carcinogens. However, it can take years of exposure to produce tumors. Why? Because we have built-in protective mechanisms that remove DNA adducts and kill abnormal cells.
Patient deaths that "couldnt be ruled out as related to pirfenidone." does not strike me as irrefutable evidence of causation, either.
The overall data from both the ITMN and Shionogi phase III trials all seem to suggest that this drug increases survival. This was apparent in the Japanese phase II study where they ended the double-blind trial because the survival benefits seemed undeniable to the study reviewers.
Yes, thanks, that is the photosensitivity adverse side effect that is well documented.
It is NOT cancer. It suggests that it may cause the formation of DNA damage, but such damage is repaired routinely in everyone's skin.
The use of pirfenidone has shown to cause an abnormal chromosomal structure on exposure to light
in genotoxicity tests; therefore it is important to explain to the patient about the potential of the drug to
cause carcinogenesis of the skin on exposure to light. Due to this patients should be advised to take
appropriate measures to protect themselves against exposure to light.
– It is recommended to wear long-sleeved clothing when outdoors, wear a hat or umbrella and apply
effective sunscreens (SPF50+, PA+++) in order to avoid UV rays.