Right. The results after 14 days appears to be good after doses at day 0 and day 7. Therefore in a short term review that is what the DSMC saw. CYDY is lobbying for more dosing, days 14 and 21, which may have improved results of the study at 28 days. Hopefully they are using 4 doses in the Brazil trials.
I think that’s why there is a need to use 4 doses instead of only 2. I’m not sure why it would be a problem switching from 2 to 4 if the results for the patient is better with 4. It’s a very simple adjustment that should be allowed now and in the future. This type of scrutiny over a situation like this is unnecessary that’s what the trials should be for to figure out what makes the drug achieve the highest efficacy it can and still be safe . I’m sure the FDA would balk at us changing our dosage as they clearly would like to see our drug get shelved . Don’t worry we will eventually be used in every hospital around the world that is the end game. Yesterday I was very impatient about the revenue happening right away but we must remain calm and not easily be deterred from our investment. GLTA
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