GREY:ATBPF - Post by User
Comment by
PoorOpinionon Feb 19, 2018 12:09pm
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Post# 27583184
RE:RE:RE:RE:100
RE:RE:RE:RE:100The point wasnt about the quality of the drug ( or more accurately what it looks like now). Astrazeneca thought it was a winner before the fda decision, the market thought I was a winner (why did the SP drop 90% on the decision?), wallace thinks(in 2017) that NO pre-clinical GI data and even early human trials looked good, the blood pressure effects arent quite how you present them ( or werent then, the drug went on to be trialed as a blood pressure drug). In 2003 the drug didnt look as bad as it does now or as you present it.
The point was more to try to look for real world examples of drugs trying to enter this market to get a sense of how the market (and pharma) value them. Its imperfect but the best I've found. Anybody got any examples on how to value such drugs?
https://www.iris.unina.it/retrieve/handle/11588/682004/133093/Dig%20Dis%20Sci%202017.pdf Wallace review 2017
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NO donors exert protective effects in the GI tract through a range of mechanisms that include increasing mucosal blood flow, inhibiting leukocyte adherence to the vascular endothelium, and stimulating mucus and bicarbonate secretion [57]. Some of the beneficial effects of NO may be attributable to CO, since NO can induce heme oxygenase [58]. NO-releasing NSAIDs demonstrated greatly reduced damaging effects in the GI tract in extensive animal testing and in early clinical trials [28]. However, in a pivotal trial of an NO-releasing derivative of naproxen, a statistically significant reduction of upper GI damage was not achieved [59]. " StrikingMoose wrote: Naproxincod deserved to be dropped. It had swinging blood pressure issues and NO had no gastric protective effects. Even in rodent models they still had gastric lesions in almost the same amount as the naproxen control groups. Their claim was stable BP but in rodent it was fine however in humans NO donor moeityhalf life was only 2h so they had see saw BP Results. I am so happy Naproxincod got rejected because Wallace learned everything that was wrong from the rejection. If this trial goes well they will have fixed every complaint the fda had about Naproxincod. It was a product. 346 is not. It still causes BP swings. 346 does not. It still causes gastric lesions in rodents and humans (with similar rates from rodent to human which is fantastic seeing how well H2S is doing with rodents). Half life was only 2h for the beneficial effects. 346 is longer. Pain control was not better. Pain control is better with 346. 2 weeks!!!