Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

"Merck isn’t simply going to get a pass on this from the FDA."

Zero hedge expressed serious concerns about Molnupiravir.

https://www.zerohedge.com/news/2021-10-01/mercks-therapeutics-waiting-wings-faucis-removal

"Today news of Merck's Molnupiravir is dominating the narrative. In dramatic fashion they are stopping the trial recruitment and plan to file an EUA. While this is fantastic news people can’t be blinded by the Merck aura and have to dig into the news to truly understand the ramifications. This is a drug with known mutagenicity. Ironically Merck’s inclusion criteria in ALL their clinical trials required participants to not have sex. This includes the clinical trial for prophylaxis. Perhaps they want to avoid the potential of birth defects so this drug is clearly not going to appeal to anyone building a family or engaging in intercourse.

The drug is using the virus’s propensity to mutate against itself by tricking the replication machinery to pump out reproduction errors until the virally infected cell collapses. The last thing the FDA wants to do is approve a drug that brings the rise of a new class of variants. It's unclear if Merck tested patients for new variants that are more likely to rise up in patients who have the longest active infections. Merck isn’t simply going to get a pass on this from the FDA. Based on the commentary in the Merck press release it's unclear if Merck even knows if their drug is safe. Essentially they talk about the incidence of drug-related adverse events as the same, but didn’t provide any color on what these events were.

"The euphoria from this news announcement isn’t looking at the fine print of the trial design of the study. Recruitment required at least one underlying medical condition like obesity, old age (>60 years), diabetes, or heart disease. Looking at this patient population was needed to obtain statistical significance because too many with no underlying conditions just get better on their own. The trial could have been a failure otherwise. Another factor contributing to Merck's success is a smaller than expected stratification of Delta variant infections. Only 40% of the clinical trial had Delta variant patients. People need to consider that a majority of the data was from the alpha variant which means that if Merck doesn't segregate the data by variant they are trying to pull the wool over our eyes to hide how weak the data really is."

GLTA,

Farrell