Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-132

First 132 Last

Share
Profile

Follow
Baremoney

236 Posts.

59

09/06/21

19:13

Post #: 53750875
Share

Originally posted by Vinceanna: ↑

The best part of this report should be the following:

Regulators’ expectations appear to be aligned. While final feedback from the EMA is still pending, the feedback that ANP has received to date indicates that the FDA and EMA both have similar expectations regarding the key features that should be included in the design of a pivotal trial of ATL1102 in non-ambulant DMD patients, including the patient population, treatment duration and primary endpoint. The key difference appears to be the FDA’s requirement for a 9-month animal toxicology study (est. cost $1-2m). The fact that the FDA would allow dosing of patients to commence before the 9-month monkey study is complete (providing a draft study report is submitted before the duration of dosing exceeds 6 months) may allow the initiation of the monkey study to also be deferred until after the topline data readout; given that by then safety data would be available from 12-month dosing of human study subjects it is possible the monkey study may no longer be required (subject to FDA feedback). If the results of the European Phase IIb trial are positive, ANP might consider applying for US approval based on the European trial data without conducting a separate US pivotal trial, subject to the feasibility of such a route.

Expand

Thanks mate, you're starting to become one of the handful of names i look forward to seeing come up in discussions. But my oh my all that and only a pitiful 27c valuation. Go figure

ANP Price at posting: 21.5¢ Sentiment: Buy Disclosure: Held
6 Upvote

0 Great analysis

Reply

Top Stories

ASX200 dives as inflation clocks in at 4% – higher than 3.8% consensus

SFX

Sheffield Resources achieves milestone production, shipments at Thunderbird, WA

SS1

Sun Silver gets that drill to thrill feeling from high grade hits at Maverick Spring

NIM

Nimy extends sulphide targets at Mons with new anomalies identified

NXM

Drilling at Bethanga shows signs of Cu-Au porphyry system for Nexus

There are more pages in this discussion • 60 more messages in this thread...

First 132 Last

Add PER (ASX) to my watchlist

(20min delay)
Last 8.1¢		Change -0.001(1.22%)		Mkt cap ! $73.02M

Open	High	Low	Value	Volume
8.0¢	8.3¢	8.0¢	$52.59K	651.3K

Buyers (Bids)

No.	Vol.	Price($)
1	56645	8.1¢

Sellers (Offers)

Price($)	Vol.	No.
8.4¢	109832	2

View Market Depth

No.	Vol.	Price($)
1	56645	0.081
3	153000	0.080
1	6500	0.078
2	121300	0.077
1	130000	0.076

Price($)	Vol.	No.
0.084	109832	2
0.085	4326	1
0.087	125000	1
0.089	102263	2
0.090	146175	1

Last trade - 16.10pm 27/06/2024 (20 minute delay)

PER (ASX) Chart

Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-132

ASX200 dives as inflation clocks in at 4% – higher than 3.8% consensus

Sheffield Resources achieves milestone production, shipments at Thunderbird, WA

Sun Silver gets that drill to thrill feeling from high grade hits at Maverick Spring

Nimy extends sulphide targets at Mons with new anomalies identified

Drilling at Bethanga shows signs of Cu-Au porphyry system for Nexus

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-132

Top Stories

ASX200 dives as inflation clocks in at 4% – higher than 3.8% consensus

Sheffield Resources achieves milestone production, shipments at Thunderbird, WA

Sun Silver gets that drill to thrill feeling from high grade hits at Maverick Spring

Nimy extends sulphide targets at Mons with new anomalies identified

Drilling at Bethanga shows signs of Cu-Au porphyry system for Nexus

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News