Member Info for HotblackDesiato

Google Finance showing up 17% - jolly good!

Laz - I think the sponsor is required to attend the meeting if there're points to be clarified based on what has been submitted. If the committee have reviewed all the data in the application and have no questions then there's probably no need to interview the sponsor.

Hi Laz - just to add my own speculation, IF the ethics committee reviewed our application on 27th and IF there were no questions requiring additional info, an application can get the go-ahead based on a majority decision by the panel. I don't know what timescales are allowed if the panel require more info. From what I've read, the system in Oz tries to help rather than hinder applications so unless there's some horrific flaw in the trial design then we should be ok. SOG has postulated that not establishing a MTD could be a hurdle but if the proposed cohort doses are a fraction of whatever the Tox study reached then what's the worry?

As we don't know if the sponsor was present at the meeting, we may still be waiting for the admin side to complete the minutes, get them signed off and then send out official confirmation of yes/no.

The sponsor then has to submit a CTN which can take 7-14 days to be made 'official'.

It might be that the sponsor knows the result of the ethics review but the BoD need to hear it officially via a letter before making an announcement.

If we've had to supply more info then it's the 25th May for the next meeting https://www.alfredhealth.org.au/research/ethics-research-governance/meeting-dates-deadlines

Regarding the cost of P1, I'm sure the BoD have stated they have the funds to see it through however at the last meeting they gave this response:

Q23: Do you have a 'rule of thumb' for how much per patient the Phase 1a trial will cost?
Yes, we have an estimate for the cost of the trial and we know how many subjects we intend to recruit, but the actual costs are commercially confident between us and the clinical unit.

However, we have a rough idea on costs by looking at the numbers in each cohort. The trial design states what happens to patients during the expected timelines (28 days of treatment/review) therefore we can multiply the patient numbers by the number of days by the rough daily rate for taking part. See link below

https://www.nucleusnetwork.com/au/participate-in-a-trial/

"Do I get paid for my time when I participate?

Whether you are studying, traveling, or just want to do something for others, clinical trials are a great opportunity to give back.

Make a difference, experience something new, and help people all over the world!

You will be reimbursed up to $600 per day for your time, feel good about yourself, and meet new people.

If you screen for a study and you are ineligible due to a medical result beyond your control, you can qualify for a screening reimbursement of $150 to $250. Learn more here.

We also have a referral program, where you can earn $500 per participant who you refer. Learn more here."

I'll let someone do the calcs. Just remember to add in a fee for the CRO to run the trial too.

Issue now appears fixed.

There appears to be a teething trouble - clicking on the E-mail Alerts button from the Investor Relations menu appears to jump to a page for unrelated company info (Hindistan Unilever is one). Clicking back one page takes you to the correct Sareum alerts page.

I've contacted the company that built the website to remedy this error.

I think Tim might owe me a few freebie shares.

Meh, wait 'til I post about the 737 deal...

Yup, definitely more streamline and professional looking. It's almost as if they've decided to rearrange the shop window to reflect where the companyis now.

With 737 looking to be P3 ready, any upfront payment will be enough to get 1802 well on it's way to join 1801 in trials.

Looks nifty.

Now 128.5 according to Google Finance. I wonder what could be driving that?

;-)

Hi Celtic - I asked a question a few meetings ago regarding the on-licensing of a compound to multiple pharmas and targetting a different indication in each deal. Tim said that generally a company would want an exclusive license so he wouldn't expect multiple deals.

Hi SOG - find of the century? Nah, I just got lucky by looking in the right place at the right time. Plenty of contributors here add equally to the collective knowledge. Just a shame that some on here dedicate their life to being doomsters.

Onwards!

Just been reading up on the Primary Sponsor and while there's always room for a good old ball's-up, I really feel they'll have gone over the ethics submission with a fine tooth comb - https://pharmasols.com/solutions/regulatory-compliance/

"Clients sometime prefer to handle things themselves. However, one mistake on these critical applications can throw your entire study off track. The expertise of our team can ensure that your trial is not delayed by simple errors in ethics and regulatory applications."

Based in NZ, they appear to be top-notch.

It'll be interesting to see if there is much movement in sp on Tuesday without any RNS. Anyone here with spare funds to buy might have to form an orderly queue (to coin a phrase). I doubt MMs bother with this dusty corner of the web so they may well be unaware of the progress (albeit provisional for now).

Hi Warthog - maybe not a clerical error exactly. The trial docs would have been written a few weeks ago and in the meantime the company name was changed. Still the same legal entity so nothing to worry about.

The primary sponsor is Pharmaceutical Solutions Australia Pty Ltd whereas we're 'just' the funding & secondary sponsor.
https://pharmasols.com/

Hi Dafis - seek and ye shall find: https://www.lseg.com/content/dam/lseg/en_us/documents/rns/rns-pricing-and-policy-guidelines-2023.pdf

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Hi Ahfam - round about the time we applied to the MHRA I looked through a similar company's RNS feed (I forget who) to see if they were issuing RNSs on a regular basis for their own drug trial and tried to gauge the historic sp reaction. There definitely seemed to be some merit to announcing each new cohort but the sp increases appeared to reduce as the trial progressed. I think the largest increase will be at the start of the trial and once that's all priced in, it's just a gentle tick up as and when the BoD make encouraging noises.

I don't think we'll see an RNS until the ethics approval is given (perhaps this week?). The sp will find a new level and then another if the BoD announce the first dosing. After the trial has started we might expect the sp to start a slow retrace unless the BoD keep momentum by issuing an RNS at each stage of the trial.

As the BoD do appear quite frugal I don't know if they'd consider an RNS at certain milestones as a waste of money. The benefit however would be a nudge to the sp each time. Radio silence erodes the sp so I hope they keep banging the drum for 1801 throughout P1.

If a deal for 737 comes along too then we'll see how close RMM's projections are!

A lot more info on the proposed trial - https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385555&isReview=true

Looks like the HREC meeting may have been on 27th April according to the HREC site (my assumption is based on the submission date of 29/03/23) https://www.alfredhealth.org.au/research/ethics-research-governance/meeting-dates-deadlines

Hi Blue - still awaiting HREC approval but you don't go to the trouble of adding 3 trial entries to the Oz website if there's no chance of progressing.

Start your Tuesday opening share price predictions now....