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Re: iclight post# 659704

Thursday, 12/28/2023 11:34:58 AM

Thursday, December 28, 2023 11:34:58 AM

Post# of 701424
iclight,

Thanks for posting, but your post sounds like an attempt to start rumors. I had to run this one through the detector 😶 …



“This statement is poorly-reasoned, baseless, and defamatory for several reasons:

1. **Lack of Evidence**: It makes several accusations and assumptions about intentions and actions (or lack thereof) of a CEO without providing concrete evidence to support these claims.

2. **Conflation of Processes**: The statement misunderstands the complexity of drug development and regulatory approval. Submitting for approval and getting approval are indeed different, but the statement fails to acknowledge the nuances and challenges inherent in these processes.

3. **Assumption of Malintent**: It assumes without basis that the CEO deliberately engaged in actions to impede the drug's approval, which is a serious accusation that requires substantial proof.

4. **Misrepresentation of Clinical Trials**: The claim that the CEO called for a trial change to make approval impossible is a serious accusation and overlooks the myriad factors that can lead to changes in clinical trial protocols.

5. **Defamatory Accusations**: Accusing the CEO of intentionally delaying the drug's development for personal financial gain, and of planning to blame external factors for the drug's failure, is defamatory without clear, substantiated proof.

6. **Oversimplification**: It oversimplifies the challenges of navigating the FDA approval process, suggesting that hiring certain companies could easily overcome these hurdles.

7. **Ignoring Regulatory Complexity**: The decision not to submit to the FDA could be due to various strategic or regulatory considerations, which the statement does not acknowledge.

In summary, the statement is speculative, lacks substantiation, and makes defamatory claims, rendering it baseless and poorly-reasoned.”

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-a-marketing-authorization-application-has-been-submitted-to-the-uk-mhra-for-dcvax-l-for-glioblastoma-302021038.html
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