While you were laughing your ass off did your brain and memories contained therein fall out too?
You, 25/6/21: "You should be fully aware that the approval rate of treatments for the conditions being targeted by CUV are only in the order of 5-10%." You seem here to be talking about the minimal success rates of drugs approved in certain indications, not about melanocortins as a class of drugs. It must have just slipped your mind to mention the word "melanocortin" in that post at all in fact.
You, 30/6/21: "A new indication means new trials and new approvals. The fact that there is 20 years of safety data actually means very little. eg Aspirin still needed multiple trials to be approved to treat heart disease despite nearly 100 years of OTC use. The approval rate is only 5--10%." Blimey. Is aspirin a melanocortin as well then? That's a surprise to me. Maybe you should've mentioned the word melanocortin in that post too. Would've made your point much clearer. Would've made a totally different point in fact!
Regarding safety and orphan drugs, again old, tired ground from you. We've covered this before and you've not backed up your claims.
Me 7/5/22: "We've been through this before. Never let FDA policies get in the way of your agenda hey?
"The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.""
You seem to have conflated the regulatory status of orphan drug as being some kind of marketing approval status. You revealed this fundamental misunderstanding when you said dersimelagon is already approved. It is not approved for marketing. It has orphan drug status, but cannot be sold at this point in time.
You 26/7/22: "It is already approved. The extension trial includes an extra indication (XLP). Dersimelagon has been awarded the following regulatory designations:6,7•An orphan drug designation by the EMA in March 2022 for the treatment of EPP•An orphan drug designation by the FDA in June 2020 for the treatment of cutaneous variants ofporphyriahttps://www.io.nihr.ac.uk/wp-content/uploads/2022/06/26730-TSID_10392-Dersimelagon-for-Erythropoietic-Protoporphyria-V1.0-JUN2022-NON-CONF.pdf"
Again - just to be clear - orphan drug designation does not equate to marketing approval.
Finally, OMG, Bitopertin is a repurposed drug? You've described afamelanoitide as a failed drug since it's been repurposed. Does that mean bitopertin is failed too?
CUV Price at posting:
$18.81 Sentiment: Hold Disclosure: Held
(20min delay)