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FDA verbal spanking on sintilimab





























Ashamed to be affiliated with this company; unethical for this company to put forth a so-called "informed consent" document which doesn't inform of already authorized treatments which could be employed. It shoulda been a head-to-head comparison between sintilimab and Keytruda. Shame on 'us'.

At some point, you gotta question EVERYTHING here ... the stock buybacks, the pushing out of experienced drug development scientists, experienced people everywhere to satisfy Dave Ricks' need to meet his operating expense objective with Wall Street. We are the Enron of the pharmaceutical industry.
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Ashamed to be affiliated with this company; unethical for this company to put forth a so-called "informed consent" document which doesn't inform of already authorized treatments which could be employed. It shoulda been a head-to-head comparison between sintilimab and Keytruda. Shame on 'us'.

At some point, you gotta question EVERYTHING here ... the stock buybacks, the pushing out of experienced drug development scientists, experienced people everywhere to satisfy Dave Ricks' need to meet his operating expense objective with Wall Street. We are the Enron of the pharmaceutical industry.
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Enron is a too harsh comparison, but either way the hollowing out of experience is a real concern. Trend lines are not good. At some point there will be nobody left to speak truth to power.
 












The interesting part of this is that there were a number of dissenters in the company that knew this was going to happen. Of course, they were pushed aside because Davie Boy Ricks knows zero about anything and believes anything the idiots in Oncology tell him.

I left this hell hole years ago, because this nonsense was becoming par for the course.

All remaining employees should be embarrassed and demand accountability. If you pay attention, there will come a day when you will no longer be able to look in the mirror and decide to exit gracefully.
 




I feel bad for the team who prepared for the adcom. They got dressed down by the FDA, then probably dressed down afterwards by the 12th floor (surely warned years in advance) for being unable to defend the indefensible.
 




When the FDA accuses you of lying about the meetings you had with them and threatens to make public those meeting minutes, after telling you you don’t understand Good Clinical Practices or the standard of care…..you might be Lilly.
 




When the FDA accuses you of lying about the meetings you had with them and threatens to make public those meeting minutes, after telling you you don’t understand Good Clinical Practices or the standard of care…..you might be Lilly.
I know, right? Have you ever seen this level of actual animosity towards a Lilly team's interaction with the FDA? No doubt this attempt to circumvent GCP hurts our brand.

Thinking back, this level of discourse may have gone down 20 years ago when Lilly got lambasted over shoddy manufacturing practices. Of course, the kids who are still wet-behind-the-ears employees would never understand this reference. When you force out (or ignore) experienced employees, you lose an 'institutional memory' that is so important to have in this business.
 




Company displaying an obvious desperation with the 40% discount pricing teaser.

F.D.A. Panel Rejects Lilly’s Cancer Drug Tested Only in China

"... Lilly had promoted its application by saying that it wanted to use sintilimab as a wedge to break the stratospheric prices of cancer immunotherapy ..."

"Dr. Scott Ramsey, a health economist and cancer specialist at Fred Hutchinson Cancer Center in Seattle, was among those who were skeptical of Lilly’s motives. “Yeah, right,” he commented.

“Are they talking about the stranglehold on prices that their current drugs contribute to?” Dr. Ramsey asked. “Maybe they could start by knocking 40 percent off their price” for Cyramza — a stomach cancer drug with a list price of $13,400.32 to $15,075.36 per month — and Verzenio, a breast cancer drug with a similar price.
“I don’t buy it,” Dr. Ramsey said of Lilly’s price disrupter story, and instead chalked it up to a public relations stunt.

It is well known that the F.D.A. is not permitted to consider price in evaluating whether a drug should be approved. That means that any F.D.A. decision must be based solely on whether the drug meets its standards.

For that reason, Dr. Aaron Kesselheim, a professor of medicine at the Harvard T.H. Chan School of Public Health and an expert on the pharmaceutical industry, was puzzled.

“I’m not aware of a company ever before announcing its pricing strategy just before an AdComm meeting, particularly one in which the general perception is that the F.D.A. was going to argue that the data don’t seem to support approval,” he said, referring to the agency’s advisory committee panel. “It does seem like a strategic ploy intended to inject a consideration into the AdComm deliberations that is not supposed to be considered.”
 








Anyone notice how our last 2 CEO's developed man crushes on people who made millions selling their companies to Lilly, then promoted them to the executive committee? Being a smooth talker who can convince Lilly to pay a wildly inflated price seems to be the only qualification required. Meanwhile, you barely notice the impact their companies have on our sales line.