MisterBlues schreef op 5 oktober 2020 09:52:
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Volgend stukje klinkt aannemelijk. Wie schiet er gaten in?For newer investors wondering why there's so much excitement today about the news that NeuroRx is submitting statistical data to the FDA this week, I hope this will be helpful background. If I get anything wrong, I'm sure others on this board will correct me.
Javitt mentioned last Wednesday that they had just enrolled the 102nd patient in the main IV trial, and that they need 28 days of monitoring to collect data from that patient. In August, however, he shared that as soon as the 102nd patient was enrolled, the Data Monitoring Committee would be able to see the unblinded data, and if it was really compelling, the DMC could recommend that the data be shared with the FDA and that a request be made to obtain early approval. (I.e., they wouldn't have to wait for 28 days from the day the last patient was enrolled.) The DMC could also recommend to stop the trial for lack of efficacy (which we know is not going to happen); or recommend that NeuroRx continue the trial to the end, assess the data, and then share it with the FDA.
So the fact that the company is stating that now, several days after the DMC was able to review the data, they are going to share statistical data with the FDA suggests that the data is statistically significant and compelling. Whatever the outcome will be, it's an extremely bullish sign.
Possible positive outcomes that now appear more likely include:
- stopping the IV trial and granting approval of the IV treatment for patients in critical condition;
- approval granted with a condition of monitoring and reporting data on all 144 patients, continuing as an open label study;
- EUA granted (bolstered by the additional data) with a requirement that the main IV trial be completed with all 144 patients before full approval will be considered;
Keep in mind that the data in the report about the 21 patients from the expanded access program at Houston Methodist Hospital showed dramatic improvements with well beyond the statistical significance that the FDA typically requires. So for most longs, the expectation has been that if the results from the main IV trial were anywhere close to what was seen in the data reported so far from the expanded access program, full approval was very likely.
We may be on the verge of RLF-100 becoming the first therapeutic for COVID-19 to receive full approval from the FDA, and the new standard of care for COVID-19 patients in critical condition.