Ann: Update on meeting with US FDA, page-34

First 34 Last

Share
Profile

Follow
discreet

210 Posts.

10

07/06/18

16:21

Post #: 33570457
Share
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.
RCE Price at posting: 19.0¢ Sentiment: None Disclosure: Held
2 Upvote

0 Great analysis

Reply

Top Stories

3DA

To make modern missiles, you need 3D Printing. And in that gold rush, Amaero is selling shovels

CPV

ClearVue inks deal with UK heated glass player to combine solar tech with its offering

MKT

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

AR3

Overland drilling proves promising for Australian Rare Earths' uranium hopes

Trump is President Again: What Does This Mean for Crypto?

There are more pages in this discussion • 7 more messages in this thread...

First 34 Last

Add RCE (ASX) to my watchlist

(20min delay)
Last 48.0¢		Change 0.010(2.13%)		Mkt cap ! $108.9M

Open	High	Low	Value	Volume
47.0¢	48.0¢	46.5¢	$71.45K	151.9K

Buyers (Bids)

No.	Vol.	Price($)
1	9621	47.0¢

Sellers (Offers)

Price($)	Vol.	No.
48.0¢	5	1

View Market Depth

No.	Vol.	Price($)
1	9621	0.470
1	9622	0.465
4	33259	0.460
2	19916	0.455
3	66668	0.450

Price($)	Vol.	No.
0.480	5	1
0.500	51020	1
0.505	5942	1
0.510	11000	1
0.540	6758	1

Last trade - 16.10pm 13/11/2024 (20 minute delay)

RCE (ASX) Chart

Ann: Update on meeting with US FDA, page-34

To make modern missiles, you need 3D Printing. And in that gold rush, Amaero is selling shovels

ClearVue inks deal with UK heated glass player to combine solar tech with its offering

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

Overland drilling proves promising for Australian Rare Earths' uranium hopes

Trump is President Again: What Does This Mean for Crypto?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: Update on meeting with US FDA, page-34

Top Stories

To make modern missiles, you need 3D Printing. And in that gold rush, Amaero is selling shovels

ClearVue inks deal with UK heated glass player to combine solar tech with its offering

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

Overland drilling proves promising for Australian Rare Earths' uranium hopes

Trump is President Again: What Does This Mean for Crypto?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News