Recapping

I receive emails asking me questions that are important to address. And that's a major reason for this newsletter but I realized I'm not presenting the information in a way that makes it easy to find.

If you go to the website you'll see what I mean. The full list of posts is available. While many of the posts have titles that make sense at a glance, most do not. And looking at that page, I'm missing out on an opportunity to make it easier to find the material you want to find.

As a test, I sent last week's post again, and if you look on the website you will see a short description of the post content. Next I'll figure out how to update that summary without resending each one to you. And then people will be able to find the information that interests them.

What's new this week? The contracting process is moving forward. And our Investigator Brochure is nearing completion. This is the document designed and written to educate the regulators, ethics committees and the clinical trialists on the drug and its track record, manufacturing, packaging and use.

We'll finish the draft of the Investigator Brochure and then have it reviewed one more by our manufacturing expert before sharing with our manufacturer for their input. Then an experienced medical writer will dig in, followed by a regulatory expert to assure us that all is included in the proper format. Then we submit for review - and wait for feedback.

While waiting - there will be no (or minimal) relaxing. We are starting to design the electronic database for the trial. That will continue for the next couple of months. We will set up the administrative relationships with the hospitals/clinics that will conduct the trial in Australia. And as those of you with experience starting companies know, we'll be raising money for the next trial even while starting this trial.

People ask about participating in the trial - which is so appreciated. But most of those requests come from people in the US or EU. The first trial will not be conducted in either, unfortunately. Why Australia? People often think it is because of its reputation of being cheaper. It was 10 years ago, but doesn't seem to save much money at this point. As I discussed in an earlier post (which I am having trouble finding), a project generally needs to choose two of three to prioritize - cost, speed or quality. Our collaborators in Australia bring us quality at the highest level - scientifically and operationally, as well as speed. And the cost seems reasonable compared to other options, so it feels as if we are getting 2.5 of 3, which is a good reason to go to Australia.

As I asked last week, please forward this to 5 people who may be interested and ask them to sign up.