Wonkish

Chemical vs. drugs (Part 2): How do you discriminate? / More on halicin

This newsletter is part of a series — here are the links to Part 1, (this one is Part 2), Part 3, Part 4, and Part 5. Also relevant is the 5 April 2024 newsletter entitled “48,015 → 0: Antibacterial Discovery Is Hard. Really, Really Hard.“ Dear All (wonkish note alert!), The recent newsletter on chemicals, drugs, and halicin (link, see

Read More »

Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)

Long and wonkish note alert — please refresh your coffee before you start reading!  Dear All: I was able to attend and speak at the 12 July 2019 Public Meeting organized by FDA on the LPAD (Limited Population Antibacterial and Antifungal Drug) pathway. The current draft guidance is here and the meeting agenda is found here. The meeting

Read More »

FDA workshop: Insights on inhaled antifungals and antibacterials

Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to

Read More »

In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to

Read More »
Scroll to Top