Hi guys,
See below for my email questions and answers. Hope this helps to clarify a few points.
My key takeaways from the email are:
1) Recce is available right now through the SAS at any hospital in Australia.
2) Having Recce avail through SAS means we will get to see efficacy and almost have a second trial running in parallel with the safety trial (will give us some evidence of the drug working in real life situations - this is pretty exciting) Normally you would have to wait for the end of phase 2 trials to see results!
3)This next 12 months will have plenty of news flow for shareholders.
4)The fact that he said n/a to the first question could possibly imply that the FDA go ahead time frame is known but not in public domain - could be imminent?
Hi Blank (Goldmad),
Thank you for these well considered questions.
Have attempted to respond and trust you may appreciate the occasionaluse of ‘N/A’ below. Not seeking to avoid the question, but am simply unable togive preference to information yet disclosed in public domain.
Welcome discussing further any time.
Kind Regards,
James
James Graham | BCom(Entrepreneurship), GAICD
Executive Director
Hi James, hope all is well.
Looks like your most recent presentation has woken up the market! Exciting times ahead!
I am hoping you could take a few minutes to answer some of the questions I have relating to the clinical trial and also the special access scheme?
In relation to the in human trial of Recce 327
- Do we have an approximate time frame that you are expecting to get FDA go ahead? N/A
- Once we get go ahead, how long after do you expect to be able to “start the trial”? Phase I trials typically go through a series of stages, which from start to completion take approximately 12 months. E.g. which clinical research organization will be running the trial, Ethics Committee Approval within that facility, patient recruitment, first dosing, completed dosing, preliminary data read-outs, Quality Controlled data assessments (final). Naturally a few news flow events along that well-trodden path.
- Is the trial mainly a safety and tolerability trial and most likely small in size and if so approximately how long will the trial run for? Also if so, will there be reports/hints of efficacy? A Phase I clinical trial will usually involve 10-20 healthy individuals – Safety. It important they are ‘healthy’, so any changes in the patients most likely due to the introduced variant – the study drug (RECCE 327). No hints of efficacy are therefore applicable in such protocol, but would be ideally be complimented with parallel SAS activity – efficacy focused.
Addedpoint – the beauty of efficacy it’s extremely easy to tell whether a compoundsworking when assessing sepsis. Bacterial count in blood (infection) goes up –not working (never seen in our studies to date). Bacterial count going down –it’s working. Better still, in SAS cases it’s likely those patients haven’tseen a bacterial reduction through other antibiotics and if one was achievedthrough use of RECCE – a medical first.
In aclinical study setting, that means less patients and less time monitoring thanstudy of a traditional drug – black and white whether bacteria still present(source of problem).
- Is the study design/trial already complete or is it a case of once FDA approval happens, then you will get to work on the design? See answer to question 2
In relation to the Special Access Scheme
- Is Recce 327 available under the SAS right now for patients in a hopeless situation or not yet? Per previous disclosures “Under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS), Category A, Recce is permitted to supply RECCE® 327 to Australian medical practitioners in defined circumstances.” – attached for reference.
- If its not available yet do you have an approximate time frame that you would expect it to become available? See above answer (question 1)
- Is it only available at Royal North Shore or will it be available at all hospitals? The TGA SAS-A relates to ‘medical practitioners’ (not specific to a hospital or person). Multi-drug Resistant infection/s exist in all hospitals of Australia and are natural places for discussion.
- Lastly once it has been used in a patient in a hospital under the scheme, will you be notifying the market of outcomes which could give us a glimpse into human tolerability/efficacy. Our ASX Continuous Disclosure Obligations strongly support such a disclosure being made at or around that time. Whether it is a single patient, or a small number of patients, that is deemed an appropriate figure so as to avoid potentially misleading the market (either way), is the more challenging question...
(20min delay)