[The following notes on Fibrogen (FGEN) are from November 2019. Re-upping it for a tiny victory lap. The company has known for years that the data was bogus. – Editor]
Both Fibrogen (FGEN) and AstraZeneca (AZN) have replied to reporters (but not the investing public at large) recently in response to the recent posts (see here and here) where we examined the Roxadustat DD-CKD data.
Here at BuyersStrike! HQ we take accuracy seriously and if there is a material error of fact in a post, we will gladly set the record straight, and punish the offending intern with complicated coffee orders and only bags of nickels to pay the pizza guy. However, we believe that both Fibrogen’s and AstraZeneca’s responses do nothing more than continue to misdirect investors and fail to address the key points of the posts. So, here are some specific questions for both AZN and FGEN (and their sell side shills) to answer in order to truly clarify the safety data for Roxadustat.
Fibrogen:
In a Bloomberg article published on November 12, Fibrogen is reported to have replied to the author in an email statement that “[the report] contains many inaccuracies”. Yet Fibrogen fails to point out a single one. Nobody here at HQ will be holding their breath waiting for FGEN to actually set the record straight. While they try to gin up even a single “inaccuracy”, perhaps CEO Jim Schoeneck would also like to answer the following questions:
- Why do you present the ITT data for the NDD-CKD population but not for the DD-CKD population? This is a very simple analysis to perform and you already have the data. Appreciate that it is YOUR unwillingness to share it that causes smart investors to be skeptical.
- Why did you omit the PYRENEES study from the pooled statistical analysis when it compares Roxadustat to the prevailing standard of care? The weak excuse that two different active comparators were used in the PYRENEES study ignores the reality that:
- Both were considered standard of care (which was the intention of the study).
- There is an unquestionable death imbalance (more deaths in the Roxadustat arm).
- Astute readers will note that you refuse to state in any of your press releases that for the pooled analysis of ROCKIES, HIMALAYAS, PYRENEES, and SIERRAS:
- There is no death imbalance in the ITT population.
- The safety endpoint of non-inferiority in time to all-cause mortality in the intent-to-treat DD-CKD population was met.
- The safety endpoint of non-inferiority in time to first MACE in the intent-to-treat DD-CKD population was met.
You have a fantastic opportunity to do so right now. Go ahead Jim.
- In the November 11th conference call with investors and analysts, a simple yes/no question was asked but was not answered:
As appears to be the case with analysts these days, the person asking the yes/no question seems completely fine with a confusing, non-binary (or is the proper terminology “reality-non-conforming”) answer and doesn’t bother to follow up. We believe this simple question should have been answered. This is another great opportunity for Schoeneck and his crew at Fibrogen to set the record straight and provide an answer to the question.
Public companies do not generally hide good news. If Roxadustat is safe in the DD-CKD
population FGEN should gleefully disclose the full data set so physicians and investors alike can evaluate it on its merits.
AstraZeneca (AZN):
AstraZeneca, also in an emailed correspondence to a Bloomberg reporter stated “the exclusion of the Pyrenees data from the safety analysis was agreed upon with the regulator.” We understand that AstraZeneca may not have any input into the statements Fibrogen makes so in addition to the questions above, there is a very simple one below:
- Why would the regulators agree to omit from the safety analysis a clinical study with a clear all-cause mortality imbalance that sheds light on the safety profile of a drug?
Ah, the sound of crickets in Andorra.