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32.5¢ botanix pharmaceuticals ltd

excellent colour. Thank you.

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wilddman

156 Posts.

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16/05/24

10:03

Post #: 73850863
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Originally posted by Chebbbit: ↑

definitely still a risk but quite low. maybe some people are also true to the sell in may go away approach :/

for those interested there's a FDA study tracking 12 years of FDA NME applications (302) and FDA rejections (151 of 302) even of those receiving CRL for safety 62% were approved, for efficacy only 31% approved. and of thre original rejections labelling issues were only 15% of original rejection reason.

for the study the "drugs never approved" due to labelling was zero. this included labelling as a standalone (instructions) and labelling related to chemistry manufacturing and control

can't paste a link but if you search DOI 10.1001 / jama.2013.282542 the article is titled "Scientific and regulatory reasons for delay and denial of FDA approval for initial applications for new drugs, 2000-2012" with Sacks as primary author

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excellent colour. Thank you.

BOT Price at posting: 26.0¢ Sentiment: Buy Disclosure: Held
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Last 32.5¢		Change 0.000(0.00%)		Mkt cap ! $592.7M

Open	High	Low	Value	Volume
32.5¢	33.5¢	32.5¢	$1.302M	3.974M

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No.	Vol.	Price($)
14	713153	32.5¢

Sellers (Offers)

Price($)	Vol.	No.
33.0¢	215665	6

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No.	Vol.	Price($)
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1	4513	0.340
3	122259	0.335
8	234694	0.330
19	1019241	0.325

Price($)	Vol.	No.
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0.300	19766	2
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0.310	24403	6
0.320	199882	2

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