RCE (ASX) Ann: Update on meeting with US FDA

Originally posted by baldymyer ↑

See below response to my latest emails.

Thanks
Baldy

Thank you for your reply.

By the sounds you’re just about as passionate about what we’re doing as we are and do hope my response is viewed accordingly. I have taken the liberty of paraphrasing your questions, as there’s quite a few topics to cover here (hope you don’t mind):

Q1 – ‘Drug trials take a long time, what’s reasonable to expect here’?
Comparatively, antibiotics are short - easy to tell whether a patient lives or dies. Publicly available data will show one can typically expect Phase I – Safety (12 months), Phase II - Efficacy (12 months) & Phase III large combination of the both (around 18 months).

Q2 – ‘Is RECCE 327 to be administered over weeks or months?’
Weeks or months? Certainly not. In our QIDP Designation announcement we said “Recce’s application to the FDA is for RECCE® 327 as a broad spectrum antibiotic, used intravenously". IV dosing as announced and assessed in animal studies is a considerably shorter treatment, generally around 24 hours or so. The average stay for patients admitted to hospital with sepsis is currently around 9 days – we have no interest in extending that. Based on significant data presented and reviewed by the FDA, guidance was received regarding a rationale for IV dosing in humans.
I further note that dosing for safety/efficacy is generally fast to complete – it’s the significant study set-up and post application analysis and documentation that takes the time (and is the value here).

Q3 - ‘Do we intend on releasing the minutes from the FDA meeting(s)?’
In short – no. Todd, as a valued and growing in interest shareholder, I feel it is important I be clear on our philosophy here:

This is a commercial endeavour - We take a Pharmco ‘Johnson & Johnson’ approach, there is no ‘research for research’ sake here and I will not be drawn by potential ‘short-term gains’ of educating the public on the ins and outs of our technology, studies and confidential FDA correspondence – you’re either educating your competitors or begging the all too often naive speculator to have a go

Continuous disclosure obligations – we take these very seriously, any material event is reported and goes through a stringent process, including legal review - prior to release

Q4 – ‘US President has signed a Right To Try bill’
Well spotted! My reading of the Right to Try Act suggests that in the US (48% of world antibiotic market), patients with life threatening diseases, can now get direct access to potentially lifesaving drugs, years ahead of approval - post phase 1 human testing.

Without any suggestion of any strategic decisions or otherwise, reading in to the opportunities, one could see:

Early Revenue Generation - Drug manufacturers are permitted to sell the product under the scheme (doctors/drug makers indemnified), though not profit - early sales and demonstrate market demand

Direct to market distribution – Drug sales have traditionally been an all or nothing sales/distribution business, determined by final approval. This bill may incentivise drug manufacturers to contact doctors/hospitals well ahead of anticipated drug approval, for them to procure supplies for their many, reoccurring, patient demands. This could disrupt the traditional pharmaceutical business model and open up related opportunities.

For us, the Right To Try bill may bring the traditionally longer term opportunities to the medium.

I trust this response has been helpful and wish you the best with your investment.

Kind Regards,
James

Expand

Thanks Baldymyer for sharing. Judging from their response, they are one of a number of companies. Based on this, I think the investment return potential maybe a double and not a tenbagger.

No.	Vol.	Price($)
1	1263	46.0¢

No.

Vol.

Price($)

1263

46.0¢

Price($)	Vol.	No.
46.5¢	11173	5

Price($)

Vol.

No.

46.5¢

11173

No.	Vol.	Price($)
3	35701	0.510
1	2928	0.505
2	29692	0.500
1	30000	0.495
1	50000	0.490

No.

Vol.

Price($)

35701

0.510

2928

0.505

29692

0.500

30000

0.495

50000

0.490

Price($)	Vol.	No.
0.520	6981	1
0.525	27349	2
0.530	10000	1
0.545	1834	1
0.550	54490	2

Price($)

Vol.

No.

0.520

6981

0.525

27349

0.530

10000

0.545

1834

0.550

54490

(20min delay)
Last 46.5¢		Change 0.000(0.00%)		Mkt cap ! $118.1M

Open	High	Low	Value	Volume
46.5¢	46.5¢	46.5¢	$2.131K	4.582K

Thanks Baldymyer for sharing. Judging from their response, they...

This biotech stock raised $11M in a risk-off environment. Its Alzheimer's drug could change the game

Breaking news: New opportunities for investors & companies - HotCopper opens to capital raising!

Metallurgical work shows gold recovery above 91% for Magnetic's Lady Julie North 4

History-making uranium sample grades and an imminent drill run. Infini Resources is poised to transform in 2025

Titan raises $20M to 'get cracking' at Ecuadorian Dynasty silver-gold project

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Thanks Baldymyer for sharing. Judging from their response, they...

Top Stories

This biotech stock raised $11M in a risk-off environment. Its Alzheimer's drug could change the game

Breaking news: New opportunities for investors & companies - HotCopper opens to capital raising!

Metallurgical work shows gold recovery above 91% for Magnetic's Lady Julie North 4

History-making uranium sample grades and an imminent drill run. Infini Resources is poised to transform in 2025

Titan raises $20M to 'get cracking' at Ecuadorian Dynasty silver-gold project

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News