Australia's largest stock trading and investment forum Australia's #1 stock forum

IMU

0.00%

5.3¢ imugene limited

Media Thread, page-12067

First 12067 Last

Share
Profile

Follow
smart spider

907 Posts.

189

03/03/24

20:13

Post #: 72721357
Share

Originally posted by Jov88: ↑

As Rolly suggested, impossible for us to know. But I have provided some thoughts below on how I see it.

The speed of approval revolves around safety and efficacy.

Vaxinia is currently in Phase I. Phase I’s are conducted to mainly determine safety (it’s the first time a therapy has been tested in a human) with the added intention of determining the recommended Phase II dose (RP2D). Or human dose that’s most effective with acceptable safety. With that being said IMU has been efficient with their design of the MAST trial to have a focus ALSO on efficacy. Which means they are gathering clinical data to confirm effectiveness.

Currently Vaxinia has proved to be safe and efficacious. However, the RP2D hasn’t been confirmed yet. Although, it’s likely they are currently at this dosage or close to it.

Once this dosage is confirmed, there will be multiple expansion trials, the first one being in Bile Duct Cancer which has already been announced and has received Fast Track designation.

Once that starts the data produced from it will really be the confirmation needed to achieve approval. It’s a smaller trial however in a rare cancer type, so who knows how long it will take to gather the 10-20 patients they are aiming for. If Vaxinia performs relatively well in this trial you could make a case for 12-18 months from commencement until an approval in granted.

That’s not to say there wouldn’t be significant SP inflection points in between with any positive announcements across the rest of the trials though. Even positive data from current higher dose cohorts in MAST could boost the SP in a big way. Not to mention OnCARlytics…

So in summary:

1. Vaxinia RP2D still needs to be confirmed (3-6 months)
2. Expansion Trial to commence and enrol (12-18 months)

With these loose estimates conservatively 1.5 to 2 years from now until approval.

Now, of course if 10 Bile Tract patients are enrolled fast, are treated and it’s looking stella (Objective response rates in most and little toxicity) it could happen faster. This is mainly due to Bile Duct cancer qualifying as a rare disease, so IMU could apply for Vaxinia to be approved as an orphan drug. Which means approval can be granted within 60 days from confirmed Real World Data from a small sample size (hence why expansion trial n=10-20) and also no requirement for a randomised trial (Phase II or Phase III). Even on this basis I’d give it 12 months minimum from now.

It could be a stroke of genius attacking Bile Tract cancer first and seeking fast approval in this space. If approved and data continues to be positive other indications will be approved ‘tout de suite’.

Cheers.

Expand

Thanks @Jov88 this answers my questions. I posed the question fully knowing there are many ifs and buts.

All i wanted to know was any prior scenario that any one aware of the process and logical end of a drug being assigned a fast track FDA.

Thanks for your response, much appreciated.
SS

IMU Price at posting: 12.0¢ Sentiment: Hold Disclosure: Held
8 Upvote

0 Great analysis

Reply

Top Stories

Trimmed CPI figure provokes market jump of 1%, but inflation pressures remain a reality

MGU

New results confirm Buena Vista's iron grades potential

MRC

Mineral Commodities to shut down Tormin mineral sands project as oil spill contaminates beach

1CG

One Click Group jumps 4% after ending quarter with $2.4M in cash; $1M in revenue and 150K+ users on board

KOB

Koba, formerly a cobalt player, gears up to become newest explorer in the uranium state: South Australia

There are more pages in this discussion • 2,916 more messages in this thread...

First 12067 Last

Add IMU (ASX) to my watchlist

(20min delay)
Last 5.3¢		Change 0.000(0.00%)		Mkt cap ! $389.5M

Open	High	Low	Value	Volume
5.3¢	5.4¢	5.1¢	$717.6K	13.61M

Buyers (Bids)

No.	Vol.	Price($)
6	1468251	5.3¢

Sellers (Offers)

Price($)	Vol.	No.
5.4¢	457393	5

View Market Depth

No.	Vol.	Price($)
6	1468251	0.053
14	1956862	0.052
30	3768447	0.051
78	7419000	0.050
25	3385007	0.049

Price($)	Vol.	No.
0.054	457393	5
0.055	878148	7
0.056	920184	8
0.057	1624353	11
0.058	1120000	6

Last trade - 16.10pm 31/07/2024 (20 minute delay)

IMU (ASX) Chart

Media Thread, page-12067

Trimmed CPI figure provokes market jump of 1%, but inflation pressures remain a reality

New results confirm Buena Vista's iron grades potential

Mineral Commodities to shut down Tormin mineral sands project as oil spill contaminates beach

One Click Group jumps 4% after ending quarter with $2.4M in cash; $1M in revenue and 150K+ users on board

Koba, formerly a cobalt player, gears up to become newest explorer in the uranium state: South Australia

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Media Thread, page-12067

Top Stories

Trimmed CPI figure provokes market jump of 1%, but inflation pressures remain a reality

New results confirm Buena Vista's iron grades potential

Mineral Commodities to shut down Tormin mineral sands project as oil spill contaminates beach

One Click Group jumps 4% after ending quarter with $2.4M in cash; $1M in revenue and 150K+ users on board

Koba, formerly a cobalt player, gears up to become newest explorer in the uranium state: South Australia

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News