A company called Merck made a medicine that can help people with a type of lung cancer. The medicine is not allowed to be sold in the US yet because some problems were found at the place where it's made. But, Merck says they will fix the problem and work with the government to make sure their medicine is safe and works well. Read from source...

1. The title is misleading and does not reflect the main focus of the article, which is about Merck's drug candidate facing FDA rejection, rather than Merck's Lung Cancer Candidate itself. A more accurate title would be "Merck's Drug Candidate for Advanced NSCLC Faces FDA Rejection".
2. The article does not provide enough context about the FDA's CRL and its implications for Merck and the third-party manufacturer. It fails to explain why the FDA inspected a third-party facility and what issues were observed there. This leaves the reader uninformed and confused about the nature of the problem.
3. The article mentions that the BLA was supported by data from a phase II study, but does not provide any details about the design, methods, results, or limitations of the study. This makes it hard for the reader to assess the validity and significance of the data.
4. The article briefly states that Merck's stock has risen 20.6% this year, but does not compare it with any relevant benchmark or explain how it relates to the FDA rejection. This information seems irrelevant and out of place in the context of the main topic.

Possible recommendations and their respective risks are as follows:

1. Buy Merck's stock, as it has shown positive results from the HERTHENA-Lung01 pivotal phase II study and has a promising pipeline of ADC drugs for various cancer indications. The main risk is that the FDA may not approve the BLA for can