Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Wasn't Denner trying to do a deal like this in the UK
What happened with the UK deal on Inclisiran . Wasn't Denner talking about trying to do the same with Vascepa ?
Kiwi
Good positive vol going into a holiday weekend .
Mkt cap on this is only around $130m. . One would think they could sell the DME indication for at least $100m since they are unlikely to pursue themselves.
Yes the drug make take 6-12 mths to reduce retinal thickness ...but given the option of an eye injection every 2-3 mths ...or starting early with a pill to reduce the need for the injection .....I'll go with the pill as long as its safe
They are still working on getting their P3 clinical hold lifted . That will be a real positive when / if it happens
Kiwi
Good positive vol going into a holiday weekend .
Mkt cap on this is only around $130m. . One would think they could sell the DME indication for at least $100m since they are unlikely to pursue themselves.
Yes the drug make take 6-12 mths to reduce retinal thickness ...but given the option of an eye injection every 2-3 mths ...or stating early with a pill to reduce the need for the injection .....I'll go with the pill as long as its safe
They are still working on getting their P3 clinical hold lifted . That will be a real positive when / if it happens
Kiwi
How long did Denner own MDCO ? Thats what I was looking for ...a flip to NVS .
I owned MDCO before Denner got control of their BOD .
Re timing of share buy back ...I'm assuming ..if approved ..they use that to get the PPS over $1 and short circuit the Naz delisting process once again .
Really need sales in the EU to ramp to get this Co moving ...or at least a convincing plan on how they intend to do that rather than the same ol same ol
Kiwi
Well RZLT is up 10% this am ....sooooo hmmm
Besides DME they have a clinical hold on their main program and are working to get the FDA to lift that . If the FDA does do that ...stock should jump.
May write something later on why I'll probably add to UNCY ...so I'll have a record of my thinking in case I do a face plant on this
Kiwi
Regarding RZLT ...at least their DME program
This post from some one more knowledgeable than moi
Thx for the response . If you have time could you take a look at UNCY .
Their pivotal trial will readout probably in the next 2-3 wks. .
I've made some comments on the UNCY board and would appreciate your critical eye if you're so inclined .
Kiwi
RMB. I think I mis understood their intended meaning re AE's
Believe they were the same in TEAE's and in AE's .
I've been doing more DD on UNCY ( see recent posts ) and may add tomorrow . I have done well in NVDA which I've owned over a yr ...so may use a little of that on a binary risk readout ...yikes
Kiwi
Title: Two-Way Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate
Lead Author: Vandana Mathur, MD
Results:
This board is the only place that complains about the high copay ???...guess you don't know any Nephrologists especially those with mainly Medicare / Medicaid patients
Re Xphazoh ...the high copay IS the number one compliant. My wife is authorized to prescribe it but none of her Medicare / Medicaid patients can afford the copay .
She and the Nephrologists she works with would like to try it on their patients that complain of constipation ( since X can cause a loose stool ) and whose Pho levels are way to high . Even after going thru the pre authorization hoops ( yes they are real and a drag ) unless ARDX is willing to find a way for these patients to afford X ...it's not getting used.
In the non Medicare / Medicaid population it's getting used because the Co is offering generous coupons .....which effectively cut the cost significantly .
Are they making $ doing that .
We'll need to see how they account for this as I think right now they are just disclosing Revenue ...not the actual profit / loss on X once the coupon costs are factored in . If you can show me how they account for the coupons and if they are making any profit ...please do .
Regarding recent stock price of UNCY.
Co will be very careful to guard the data until it can be publicly released ...which is likely in the next 2 -3 weeks.
Chk the Sept 2023 chart of SLNO ....stock slightly tailed off right before the data release . Vivo Capital had a big position in that Co as they do in UNCY.
There is risk here . Suggest you risk only what you can afford to lose because if trial fails the stock will trade close to remaining cash on hand
Kiwi
RZLT ...some follow up re your comments
Fierce Biotech article on DME trial
Fierce Biotech article on DME trial
North. Congrats on reaching 87 + and your investing skills .
Kiwi
Congrats North. NVDA is my 3rd largest position (after AMZN and MSFT ) trading around $1,008 as I type .
We need a catalyst to get AMRN going ...hopefully UK approval of the share buy back will help.
Kiwi
RMB. In the CC the Co thought the difference between the 400 mg and 200 mg dose was that there were more with advanced DME in the 200 mg dose .
So those with limited DME ...more of them in the 400 mg cohort ...saw limited benefit as not a lot to improve on.
So the challenge is to recruit those with moderate DME who aren't yet taking the eye injections
Kiwi
EOT was the data they stopped taking the drug . Then there was a 2 wk follow up to see if there was any lingering benefit ....which they recorded for the 200 mg dose .
The problem is that they say there was probably full cell penetration at the 200 mg dose so there was no benefit from a larger dose ...however ...if there was full cell penetration at the 200 dose ...and the 400 dose ...those graphs should be the same or close .
But they aren't
Kiwi
Dew. Good call re RZLT
. Markets not buying the data ...or at least expecting a capital raise for the Co to prove it
Option may be to run a larger P2b trial for 6 mths with DME patients confirmed in decline ?
Aim would be to see at what pt BCVA ( visual acuity ) improved .
Co maintains 3 mths is to short a time to see improvement in these patients ...but 6 mths on treatment should do it.
4th option is to run a larger P2b trial for 6 mths with DME patients confirmed in decline .
Aim would be to see at what pt BCVA ( visual acuity ) improved .
Co maintains 3 mths is to short a time to see improvement in these patients ...but 6 mths on treatment should do it.
Benefit from the injections kicks in fairly fast
RMB. some skepticism over the results ...expressed on Twitter ( X )
$RZLT
https://x.com/BiotechElmo/status/1793035993991266771/photo/1
Kiwi
RZLT.
RMB ..re those comments ...which is why I'm stunned by the markets reaction ...which apparently is " sell the news " on steroids
Kiwi
Good luck . I didn't expect this sell off. Co is going to sell or partner for the DME indication and market is saying the data may not be good enough to attract BP interest.
Here we have the first oral drug that may delay the need for eye injections in treating DME ....and the stock tanks !!!!!
Kiwi
Ha. thx Steve ...however the market seems to share the view of Dew and Worst Luck ... RZLT .data may not be good enough to hook a BP buyer for the DME indication.
Next up this Qt is pivotal data from UNCY
Hope you are well
Kiwi
JR. Agree with your view especially since the buyback uses less than 25% of their cash on hand .
Thx Zip. appreciate the feedback.
Kiwi
RMB. There was a camp out there in around 1920's mining sulphur ...same thing happened to them .
We never went out there but did go to Whale Island once ( named by Capt Cook ) ...Volcanic Island that erupted side ways ,,,so you climb about about 1,000 ft on one side to be met with a shear cliff of hundreds of feet on the other side ..once you reach the top. .
Zip. OT did you treat DME patients at all ? I'd be interested in your opinion on RZLT ...see my comments on that board
thx
Kiwi
FFS. we are anticipating a volcano ...just not like this one near my home town .
https://www.imdb.com/title/tt21439528/
Kiwi
RZLT CC. key pts
1) Co is unlikely to advance drug themselves ( so probably no capital raise after this :--). Mgt says to big a market to take on by themselves .
2( They would expect to see BCVA improvement by 6 mths ...theres a lag response to reducing retinal thickness .
3) Retinal specialists say multiple eye disease indications may benefit from this drug RZ402 ...far larger / longer trials with 3 mth , 6 mth and 12 mth data warranted . They want to start RZ402 early to delay need for eye injections and then later use with the injections if needed. Many ways to use the drug ...standalone and in combination.
Kiwi
RZLT CC. Dew key pts
1) Co is unlikely to advance drug themselves ( so probably no capital raise after this :--). Mgt says to big a market to take on by themselves .
2( They would expect to see BCVA improvement by 6 mths ...theres a lag response to reducing retinal thickness .
3) Retinal specialists say multiple eye disease indications may benefit from this drug RZ402 ...far larger / longer trials with 3 mth , 6 mth and 12 mth data warranted . They want to start RZ402 early to delay need for eye injections and then later use with the injections if needed. Many ways to use the drug ...standalone and in combination.
Kiwi
This is the first safe oral therapy that I'm aware of that reduces retinal thickening and is likely to at least enable these patients to retain their visual clarity if treatment is started early enough.
Without a drug like this , patients require injections into their eye usually every 3 mths.
The problem with selling a Co like this ...with a drug that appears to be a major advance in therapy ...is trying to time when to get back in .
Kiwi
Dew I think investors are looking at
bio. thx for the update .
I hadn't paid much attention to your VLDL number as Kaiser doesn't calculate it on my lipid panels ...only Total cholesterol , TG's , HDL and LDL
Your last numbers ( corrected ) look good .
Kiwi