We would love to hear your thoughts about our site and services, please take our survey here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
SP
No oral iclaprim safety data has ever been reported anywhere, except this mention of the elevated LE levels from oral iclaprim in the 2008 Arpida AR which stated;
Oral iclaprim in cSSSI - in-depth analysis ongoing for further design of development plan
In December 2008, Arpida announced the top-line results of a Phase II "intravenous-to-oral" switch trial with iclaprim in patients with cSSSI. In parallel with the Phase II trial, the last ongoing study of the Phase I programme has been closed. Based on the review to date, Arpida expects that further development work will be required in order to better understand the effect of orally administrated iclaprim on liver enzymes and to explore optimal dosing‘
I‘m pretty sure Huang hasn‘t discussed any detailed elevated LE data or Hy‘s law cases with oral iclaprim (please correct me if you know otherwise). So we still don‘t what the oral data showed or why the FDA was so spooked by it.
They cannot invest with so much going on,their inside knowledge would get them nicked !
Instead of just congratulating each other for showing up for work, why hasn't MTFB described what the issue raised by the FDA with oral iclaprim actually is (what proportion of patients presented with elevated liver enzymes (I guess that only about 50 patients were ever treated with oral iclaprim, including those in the iv to oral switch study, so the incidence must have been a lot more than 3%), how many at 3x, 3-10x and >10x ULN? Any instances of Hy's law etc., etc., and the proposal(s) that have been made to address the issues raised?
It's not possible to prove a negative (no risk of DILI), only to estimate the level of risk. GL already suggested a powered, controlled study including efficacy endpoints would be required (large numbers will be required to identify and follow elevated LEs for the required time to assess outcomes, sequelae etc. If a major new phase 3 study is not being proposed, shouldn't he explain what has been proposed and why? Of course he should but strategically this would be a bad move, for obvious reasons.
BTW, I still think it will be WRO. A meeting would be a positive!
Type B meeting 60 days response time - that’s takes us into Sept. problem is the money runs out by then!