Friday, May 29, 2020 6:30:43 PM
It is possible that Biostock and F1ash are right and the 10 and 20 refer to the mg tablets and 30 and 50 mg to the doses. Yes, it is easy to mathematically combine 3 identical appearing pills to get 0, 30 and 50 mg and that allows the central AVXL storage to have fewer unique pills and allow for later possibility of titration. Pills are cheap to make (pennies/pill on top of the investigational drug cost and I don't think its any easier or cheaper to have multiple bottles with 10's and 20's vs fewer bottles with 0, 30 and 50. Additionally, this complicates the instructions for the patients and caregivers (who may be past prime or with poor eyesight). Which is easier and less prone to error: to tell an elderly couple to take 1 pill from one bottle or to take one from bottle A and two from bottle B --- especially when they will all look the same
During a study, patients are given bottles that are uniquely identified by code numbers. Patients likely have several visits over the first 3 months but then will have visits every 12 weeks for the second half of the study. Most studies I've been in with pills have bottles containing 30-35 pills (4 weeks plus a few extra since visit may not be exactly 4 weeks or 12 weeks away. So with A + 2B, patients may need to leave with 9 bottle instead of 3.
We will know in another 4-8 weeks. Since there are advantages and disadvantages to either combination (10/20 vs 30/50), its not a huge deal and I still don't get why Missling is being secretive with the dose. MacFarlane apparently told the Alfred reporter 30 and 50. Did he violate his NDA again? If Public relations/reporters who do not have non-disclosures know the dose, what possible reason is there to hide the dose from investors (especially those from 2014)?
Every study I've done has disclosed the correct doses being tested in the clinicaltrials.gov database so this is not typical. However, without wasting time looking at hundreds of studies, I can't say leaving the dose out is unique.
As another point, it is possible that there could be a titration to the ultimate 30 and 50 mg dose. One study I was in had a titration but the clinicaltrials.gov listing did not clearly state this. Protocols are 80-140 pages long so only the highlights are listed in the registry. That study had a tiny dose and the standard dose tablets and patients were given one bottle of small pills to increase from 1 to 4 pills daily over a set time and then subsequently were on one of two larger dose pills at the first follow up visits.
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