Hi All, I am new to this thread and love to see both positive and constructive feedback on this stock.
I appreciate if people can provide more in-depth knowledge of the Necropsy after monkey's death:
During necropsy, organs such as the liver, kidneys, heart, lungs, and brain are carefully examined for any abnormalities or signs of toxicity. Additionally, samples of these organs may be collected for further analysis, including histopathological examination under a microscope to assess cellular changes.
While some information can be gathered during the living time of the monkeys through non-invasive assessments such as blood tests and imaging scans, necropsy provides a more comprehensive understanding of the effects of the biotechnical product on the body's organs and tissues. Certain changes or abnormalities may only be detected through post-mortem examination, allowing researchers to evaluate the full extent of toxicity and its potential implications. Overall, necropsy plays a crucial role in toxicology studies by providing valuable insights into the mechanisms of toxicity and helping researchers make informed decisions regarding the safety of the biotechnical product.
Once the analysis is completed, the findings are compiled into a comprehensive report, which is then submitted to the FDA as part of the regulatory approval process. The timeline for providing evidence to the FDA after the completion of the analysis depends on various factors, including the specific regulatory requirements, the complexity of the study data, and any additional questions or requests for clarification from the FDA. In some cases, the submission of evidence to the FDA may occur relatively quickly after the completion of the analysis, while in other cases, it may take several months or longer to compile and review the data thoroughly before submission. Ultimately, the goal is to ensure that the evidence provided to the FDA is accurate, complete, and meets regulatory standards for assessing the safety of the biotechnical product.
Positive mindset: PER had a good run (reading between the lines from JG on his presentation last year ) while the monkeys were alive.
Critical mindset: There is no guarantee about what clinicians may find within necropsy. (To guarantee PER with accelerated FDA ticket???)
I tried to go deep and check Exondys 51 (eteplirsen) developed by Sarepta Therapeutics FDA approval, but I could not find a reliable source to compare: While monkeys were alive vs monkey's body studies within necropsy.
Your thoughts or sources that I can cross-check.
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