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seeva222
Posted on: Today, 11:43 AM


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PW and team should be moving heaven and earth to get Scenesse into the hands of patients in Columbus and Boston.
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seeva222
Posted on: May 25 2020, 09:40 AM


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no, thats right it was 41k when I called.
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seeva222
Posted on: May 24 2020, 03:44 PM


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Simone give that woman free Scenesse
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seeva222
Posted on: May 24 2020, 05:10 AM


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Hey PW, what's your competitive response here? Don't sleep on this or it will bite your bonus.
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seeva222
Posted on: May 23 2020, 11:57 PM


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Hey Clinuvel. Move heaven and earth to get centers set up in their target cities. Pull in all your contacts. And get it done.
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seeva222
Posted on: May 23 2020, 10:51 AM


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Peptide used to treat corona in Cuba
https://www.reuters.com/article/us-health-c...source=facebook
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seeva222
Posted on: May 21 2020, 11:06 AM


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I believe so. Im me.
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seeva222
Posted on: May 21 2020, 09:45 AM


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BTW, one thing I haven't seen mentioned is using Scenesse at the onset of vitiligo to halt the progression of it. I suspect it will be a first line defense at the earliest diagnosis.
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seeva222
Posted on: May 21 2020, 01:08 AM


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They seem to have deemphasized M&A... phew
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seeva222
Posted on: May 20 2020, 06:11 PM


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What is the status in Japan for EPP? I don't see that anywhere
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seeva222
Posted on: May 20 2020, 09:36 AM


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If you could show DNA repair... how big would that be? That seems like a holy grail
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seeva222
Posted on: May 19 2020, 10:51 PM


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Opening new locations = printing money
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seeva222
Posted on: May 19 2020, 10:16 AM


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“ The clinical demand for SCENESSE® surpasses our expectations so far, the news reached us that more EPP patients are flying from all parts of the US to seek treatmenT”
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seeva222
Posted on: May 19 2020, 12:33 AM


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So....

    The EPP engine now looks safely into the $100-million per year + range between Europe, US, China, Japan (totally forgot about it) and Australia. When does Japan evaluate?
    Vitiligo in the US now looks very promising and the same people reviewing the NDA were the ones who reviewed EPP.
    Cosmetic, DNA repair and now it looks like sort of anti-inflammatory indications are in the works.
    VPP is progressing.


If not for corona hell, we'd be talking tax implication.s
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seeva222
Posted on: May 17 2020, 08:53 AM


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nation therapy was
conducted.
Combination therapy (n ¼ 18) was superior to
placebo, with a statistically significant decrease in the
median Vitiligo Area Scoring Index scores for total,
head and neck, hands, upper extremities, trunk, and
lower extremities at day 140 and thereafter (P\.05)
(Table I). Statistically significant reductions in Vitiligo
European Task Force area percentage scores for total
body, head and neck, and trunk were observed at
day 196 (P \.05).
Onset of repigmentation was observed the earliest
for upper extremities (median, 10.5 days) and
trunk (median, 13 days) (Fig 1) and the latest for
hands and feet (median, 36 days for both).
Combination therapy was well tolerated. Notable
adverse events included erythema and pruritus,
which were likely related to NB-UVB. Nail
pigmentation was possibly due to afamelanotide
activating melanogenesis.
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seeva222
Posted on: May 14 2020, 04:02 AM


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Anyone else first see cyanide?
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seeva222
Posted on: May 12 2020, 11:06 PM


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What email did you send to your state senators? Seems like somehting others could do if they want to.
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seeva222
Posted on: May 12 2020, 11:43 AM


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It's just sophomoric to engage in a public battle with shareholders. It only invites ridicule.
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seeva222
Posted on: May 11 2020, 11:37 PM


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"the penetrance of the EPP phenotype in the Japanese population is expected to be higher than in the Western countries due to the high frequency of the IVS3-48C polymorphism (43%) (19)." I didn't realize Japan was a large market. 126-million people. It's listed at the same as Oz. Does anyone have info on how close we are there?
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seeva222
Posted on: May 10 2020, 11:46 AM


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They've already ruled it out. Perhaps for the reasons JT mentioned.
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seeva222
Posted on: May 8 2020, 12:27 PM


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Their logic is that they didn't believe Nasdaq would add enough liquidity to warrant the switch. (That's what I remember anyway.)
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seeva222
Posted on: May 7 2020, 07:04 PM


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It makes no sense that they were aiming for just 3 centers in 2020. It's a simple freaking procedure and paperwork.
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seeva222
Posted on: May 7 2020, 12:16 AM


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https://www.youtube.com/watch?v=6k-etrnvY4s...eature=youtu.be

<iframe width="560" height="315" src="https://www.youtube.com/embed/6k-etrnvY4s" frameborder="0" allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen></iframe>
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seeva222
Posted on: May 6 2020, 11:34 PM


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A recent study by the Porphyria Center in Rotterdam (The Netherlands), in which all Dutch EPP patients are treated with afamelanotide, confirms the safety and effectiveness of afamelanotide even under everyday conditions. The 117 patients from the Netherlands spent an average of 6.1 hours longer outdoors on treatment and had a significantly higher quality of life compared to before treatment. If patients developed phototoxic reactions, they were less painful during treatment.
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seeva222
Posted on: May 5 2020, 01:40 AM


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What exactly is stopping us from rolling this out to more than 3 centres in the US in 2020? The training is simple. Coverage is in place. Is it hiring a body in the US for 80k a year to get many times that over back in revenue?
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seeva222
Posted on: May 3 2020, 12:46 PM


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Someone should excerpt that Logada presentation for investclinuvel. I'll bet that got a few instos attention
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seeva222
Posted on: May 2 2020, 10:03 PM


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I thought they exited ?
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seeva222
Posted on: May 2 2020, 12:10 AM


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Vaso-activity, anti-phlogitism and DNA Repair?

Can someone give me some perspective on this? These seem like beyond blockbuster indications. I actually thinking of buying more as we face a downturn.


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seeva222
Posted on: May 1 2020, 11:45 PM


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Uh, wow. This is exactly the investor profile we want. Long-term, strategic holds. Wow.
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seeva222
Posted on: May 1 2020, 10:30 AM


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“Most pleasing was that the senior managers and decision makers within the FDA’s Division of Dermatology and
Dental Products were actively engaged in the discussion, and they were the same professionals who had reviewed
and approved SCENESSE® for EPP in October 2019, thus the knowledge on SCENESSE® was current.

I like the sound of htis.
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seeva222
Posted on: May 1 2020, 05:31 AM


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An implant would still be preferable to oral IF you could get a local injection.
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seeva222
Posted on: May 1 2020, 02:56 AM


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I don't think the shorters care about MT-7117. They're looking at trends and liquidity.
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seeva222
Posted on: May 1 2020, 12:20 AM


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CLVLY popped $1 at the open
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seeva222
Posted on: Apr 30 2020, 02:26 AM


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https://www.facebook.com/1112753815441338/p...9530118729/?d=n
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seeva222
Posted on: Apr 29 2020, 11:29 AM


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HCQ has 90% chance of helping.

https://finance.yahoo.com/news/hydroxychlor...-155637974.html
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seeva222
Posted on: Apr 28 2020, 11:21 PM


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CUV Highlighting financial positioning.

https://www.linkedin.com/posts/clinuvel-pha...6099846145-TyMmLI

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seeva222
Posted on: Apr 28 2020, 10:27 PM


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So, is the new trademark aimed at covid-induced stroke? Or is this a coincidence? This whole thing seems out of left field.
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seeva222
Posted on: Apr 28 2020, 11:53 AM


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Roundup:

EPP: Started treating US patients with 3 centers open and expanding. Insurance reimbursement from 30 + insurers in place. Expanding into China with 5,000 patients. Oz on deck for July (150 days).
Vitiligo: Type C meeting with the FDA.
Variegate porphyria: EMA proof of concept.

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seeva222
Posted on: Apr 28 2020, 09:36 AM


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Can someone explain the significance of this? Are we talking about a drug that would impact vascular health?
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seeva222
Posted on: Apr 24 2020, 11:55 PM


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I agree,that's exactly the profile you're looking for.
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seeva222
Posted on: Apr 24 2020, 08:40 AM


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How many others are we targeting? Seems like a lot of greenfield between Europe and the US. Just give us one more indication (and I'm certain vitiligo will be one) and we're off to the races.
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seeva222
Posted on: Apr 23 2020, 06:56 PM


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This is ludicrous - there’s no reason in the world their local doctors can’t do it. Anyone medical professional and administer the implant. Hell, I’m not even sure you need medical training at all.
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seeva222
Posted on: Apr 23 2020, 10:14 AM


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A few were scheduled so unless something happened, they’ve got their implants.
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seeva222
Posted on: Apr 23 2020, 09:50 AM


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Wow. That was unexpected. US, China, Europe and Oz on deck. Vitiligo meeting happening in a week as well as cash receipts.
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seeva222
Posted on: Apr 23 2020, 09:20 AM


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Seeva222 wonders which character Ironbark222 was previously. Latest language sounds like Iggy
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seeva222
Posted on: Apr 22 2020, 03:50 AM


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What would the price be with no Covid? 30 USD at least.
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seeva222
Posted on: Apr 21 2020, 10:56 PM


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What skin conditions respond to afamelanotide?
Afamelanotide is registered to treat erythropoietic protoporphyria. It has been reported to be beneficial for patients with:

Solar urticaria
Vitiligo
Hailey-Hailey disease

Does afamelanotide work as a sunscreen?
The use of afamelanotide has been associated with a 50% decrease in epidermal cells from sunburn, as well as with a significant reduction in the formation of thymine dimer (part of the process by which UVB DNA damage ) However, marketers of afamelanotide do not recommend its use as a sunscreen or sunburn treatment.

The word is certainly gettin gout.
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seeva222
Posted on: Apr 21 2020, 01:47 AM


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Does anyone know what the hold times are on these (what their investment horizon is?) On the face of it, this looks like exactly the type of institutional portfolio you want supporting a stock.
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seeva222
Posted on: Apr 20 2020, 07:38 AM


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That is their model
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seeva222
Posted on: Apr 20 2020, 05:42 AM


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One of the problems with the euro rollout is that centers make no $$$ (at least according to one FB post. )
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seeva222
Posted on: Apr 20 2020, 05:02 AM


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That's the price quoted to me.
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seeva222
Posted on: Apr 18 2020, 11:31 PM


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If we get a handle on CV, it should be a good couple of months. The US EPP market alone is worth a $1-billion valuation.
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seeva222
Posted on: Apr 17 2020, 12:01 PM


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First implant preformed today in Miami. Type C Vitiligo meeting coming up. Cash receipts as well (could be disappointing).
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seeva222
Posted on: Apr 17 2020, 05:44 AM


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Dr. Grimes diagnosed my Vitiligo
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seeva222
Posted on: Apr 17 2020, 01:14 AM


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39k per implant off label, btw. IF it were available.
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seeva222
Posted on: Apr 16 2020, 10:49 PM


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We would certainly be over $40
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seeva222
Posted on: Apr 16 2020, 08:52 PM


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It's actually today!
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seeva222
Posted on: Apr 15 2020, 11:23 PM


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First US implant happening tomorrow.
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seeva222
Posted on: Apr 15 2020, 01:06 AM


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One day until US sales can commence. Recell announced this in January and took off in April.
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seeva222
Posted on: Apr 14 2020, 10:58 PM


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I love this. What were they at last month?
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seeva222
Posted on: Apr 13 2020, 10:27 AM


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3 Days until US treatments can commence. With the US looking to open up on May 1... we might get too far off track.
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seeva222
Posted on: Apr 10 2020, 04:41 AM


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So, who is Corbin? LH? Iggy?
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seeva222
Posted on: Apr 8 2020, 11:10 PM


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7 Days until US sales CAN commence. Have to believe the 3 centers have placed orders already.
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seeva222
Posted on: Apr 7 2020, 05:55 AM


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Find a stock that meets those criteria... curious how that has played out.
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seeva222
Posted on: Apr 7 2020, 01:37 AM


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ASX Strategies:

    Buy as a company gets into the ASX, sell after two weeks.
    If illiquid, wait for warrants to be issued and knocked out, then buy back.
    If FDA approved, sell a week after approval. Buy back a month before commercialization.
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seeva222
Posted on: Apr 6 2020, 10:22 AM


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10 days until this is available in the US.
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seeva222
Posted on: Apr 6 2020, 10:22 AM


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10 days until this is available
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seeva222
Posted on: Apr 6 2020, 03:36 AM


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What does “drop from formulary” mean?
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seeva222
Posted on: Apr 5 2020, 04:36 AM


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It shouldn't be just for cosmetics. It should be for skin protection... in Miami. What older person with skin damage isn't going to want this? It's a shame the FDA views this as a cosmetic treatment.
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seeva222
Posted on: Apr 4 2020, 11:07 PM


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I like this guy

https://www.drresnik.com/scenesse-implant-v...ami-florida.php
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seeva222
Posted on: Apr 4 2020, 12:02 AM


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Will cash flow be impacted in the short-term as these are preordered?
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seeva222
Posted on: Apr 1 2020, 05:59 AM


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About 80 per cent of the 4000 EPP sufferers in the US are covered by private insurance.
The next step is to seek Medicaid/Medicare reimbursement for the remainder.
Even though EPP is a tiny ‘orphan’ market, the company stands to generate more than $US300m ($500million) if it reaches just half the US patient market.
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seeva222
Posted on: Mar 31 2020, 11:15 AM


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We’re getting closer to US sales. If not for Coronahell we’d be at a new high in the next month.
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seeva222
Posted on: Mar 29 2020, 12:59 PM


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I do admire the approach to pricing (which is extremely hard to do and admirable) and to the medical coding which matters a great deal in the US. That said, it's time to shift strategy now to a market grab.
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seeva222
Posted on: Mar 27 2020, 12:50 PM


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Afamelanotide Works



Not to be lost in all of this
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seeva222
Posted on: Mar 27 2020, 12:36 PM


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Harris is really a douche. He’s flat out lying to people.
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seeva222
Posted on: Mar 27 2020, 09:57 AM


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He actually acted like he’d never heard of Scenesse on the vitiligo website.
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seeva222
Posted on: Mar 27 2020, 05:34 AM


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Harris is taking big pharma $$
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seeva222
Posted on: Mar 26 2020, 10:48 PM


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They should take the “clinic”’restrictions off. It’s a simple procedure with a safe drug.
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seeva222
Posted on: Mar 26 2020, 08:06 AM


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Anyone know the Whitehouse DR?
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seeva222
Posted on: Mar 24 2020, 09:43 AM


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I'll bet we'd be knocking on 40 without the world p;ossibly ending.
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seeva222
Posted on: Mar 24 2020, 05:56 AM


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They've already said they're not going to ban shorts. Too bad, coupled with US distribution and easing up on coronahell, it could really cause a ruse.
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seeva222
Posted on: Mar 24 2020, 01:07 AM


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Today would(still could?) have been the start of a year long run-up. The shorts would have disappeared. I still can't believe management is focused on topicals and M&A while targeting a lackidasical roll-out... the first rule of business is to execute your core business..
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seeva222
Posted on: Mar 23 2020, 11:31 AM


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First patient is April 15

https://yourir.info/resources/fee77b1d1a878...SA_in_April.pdf
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seeva222
Posted on: Mar 23 2020, 05:00 AM


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Can you take a breather and aggregate your thoughts? Appreciate it, but every day it's big long Wally posts. I don't read them because they're too frequent and somewhat redundant. Said with love.
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seeva222
Posted on: Mar 19 2020, 11:44 AM


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A newsletter with news
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seeva222
Posted on: Mar 18 2020, 12:39 AM


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Hey Walnut, offer up Scenesse's help if needed!
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seeva222
Posted on: Mar 17 2020, 01:54 PM


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“Short traders in the market are reportedly furious with the decisions by UniSuper, which only gives them days to return borrowed stock.”
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seeva222
Posted on: Mar 16 2020, 01:17 PM


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https://www.afr.com/politics/federal/fryden...20200313-p549p9
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seeva222
Posted on: Mar 16 2020, 10:05 AM


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Uh, yeah. Sniffing frauds out is always useful
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seeva222
Posted on: Mar 15 2020, 11:38 AM


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Perhaps I'm mistaken, I thought someone posted the critieria before.
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seeva222
Posted on: Mar 15 2020, 05:30 AM


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It will certainly be delayed. The critieria for participants was pretty wide open too. It wasn't just EPP patients, I believe almost anyone could take part. Odd.
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seeva222
Posted on: Mar 14 2020, 01:08 PM


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delete
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seeva222
Posted on: Mar 14 2020, 01:08 PM


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https://papers.ssrn.com/sol3/Delivery.cfm/S...617&mirid=1
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seeva222
Posted on: Mar 14 2020, 04:45 AM


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I would expect shorts to want to close out if they can't count on pushing th emarket down.
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seeva222
Posted on: Mar 14 2020, 04:32 AM


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If they ban shorts, I'm going to start buying.
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seeva222
Posted on: Mar 14 2020, 03:10 AM


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Italy and Spain ban shorting

Short-selling restrictions were also put in place for some Asian markets, with South Korea’s Financial Services Commission going the furthest by banning short-selling of shares listed on Kospi, Kosdaq and Konex for six months. In Thailand, short sales were not banned, but rules are being adjusted for current market conditions, according to the President of the country’s stock exchange.

https://www.bloomberg.com/news/articles/202...n-short-selling
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seeva222
Posted on: Mar 13 2020, 12:37 PM


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That will change things
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seeva222
Posted on: Mar 13 2020, 09:17 AM


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I agree. It's a liability problem masked as corporate caring. At some point the liability shifts from corporations to the individual and you get on the plane or you don't have a job.
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seeva222
Posted on: Mar 13 2020, 04:39 AM


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It's a broad-based panic sell, small caps get murdered first. The good news here is a strong balance sheet and increasing sales.
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seeva222
Posted on: Mar 12 2020, 10:46 PM


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seeva222
Posted on: Mar 12 2020, 02:56 PM


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Technology for at least four diseases, consumer goods, and different business lines. Interesting
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seeva222
Posted on: Mar 12 2020, 03:52 AM


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Unless corona virus bankrupts healthcare systems, this shitstorm means nothing to the long-term value of the company and if we're truly going to buy other companies with our cash flow, the price of acquisition just went down considerably. The problem from a shareholder perspective is that small and mid cap valuations shrink much faster than large cap in a downturn.
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seeva222
Posted on: Mar 11 2020, 12:45 AM


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CORRECTION: The Public Meeting on Patient-Focused Drug Development for Vitiligo, not the Type C meeting has been postponed. My apologies.

https://www.fda.gov/drugs/news-events-human...302020-03302020

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seeva222
Posted on: Mar 10 2020, 01:01 PM


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And it turns out Dr. Lim's Detroit Henry Ford System takes Aetna, not sure about BCBS of Michigan, but I would assume that's not a coincidence. UCLA takes Aetna as well.
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seeva222
Posted on: Mar 10 2020, 12:43 PM


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BTW, 6 doses a year for Centene and Aetna. At a 1/200,000 ratio, that's about $17-million in annually recurring revenue.
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seeva222
Posted on: Mar 10 2020, 12:11 PM


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Another 23 million insured to go with Aetna's 22 million,
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seeva222
Posted on: Mar 10 2020, 07:47 AM


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Email. Sounds corona related
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seeva222
Posted on: Mar 10 2020, 07:47 AM


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Email. Sounds corona related
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seeva222
Posted on: Mar 10 2020, 07:47 AM


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Email. Sounds corona related
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seeva222
Posted on: Mar 10 2020, 06:51 AM


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Type C meeting delayed due to “circumstances”
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seeva222
Posted on: Mar 9 2020, 11:41 PM


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I don't think they're recruiting EPP patients are they?
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seeva222
Posted on: Mar 9 2020, 11:24 AM


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Well, I’ll give Walnut credit for one thing. Strong Balance sheets are key in downturns.
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seeva222
Posted on: Mar 7 2020, 12:23 AM


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Read the annual. It’s a “self-administered” model. They seem to think they can guide this to the APF and go work on other things.
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seeva222
Posted on: Mar 6 2020, 11:00 PM


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Good chance? 50% is a pipe dream
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seeva222
Posted on: Mar 6 2020, 11:00 PM


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Good chance? 50% is a pip dream
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seeva222
Posted on: Mar 6 2020, 11:46 AM


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their entire “let everyone else do all the work” philosophy is moronic and short sighted. They’re doing it so they can concentrate on cosmeceuticals and M&A. Morons
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seeva222
Posted on: Mar 6 2020, 04:09 AM


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It's an absolute long-term bargain, but market timing is an issue. Imagine if we didn't get FDA approval?
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seeva222
Posted on: Mar 5 2020, 05:12 AM


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They didn't spend months patting themselves on the back for approval? The actually went out to monetize? Crazy
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seeva222
Posted on: Mar 4 2020, 11:27 PM


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Clinuvel should see where they’re launching and open up a Centre there. Why is it 5-7 years?
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seeva222
Posted on: Mar 4 2020, 11:27 PM


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Clinuvel should see where they’re launching and open up a Centre there. Why is it 5-7 years?
  Forum: By Share Code

seeva222
Posted on: Mar 4 2020, 09:38 AM


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CSL now #1
https://www.theaustralian.com.au/subscribe/...08aa-1583278672
  Forum: By Share Code

seeva222
Posted on: Mar 4 2020, 07:15 AM


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https://www.uclahealth.org/simon-beaven
https://www.aasld.org/programs-initiatives/...-md-faasld-agaf
https://www.henryford.com/physician-directory/l/lim-henry
  Forum: By Share Code

seeva222
Posted on: Mar 4 2020, 04:48 AM


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Guesses:
Dr. Cynthia Levy at Miami
Dr. Heny LIm at Henry Ford Hospital, Detroit, MI
LA?

BTW: https://www.drresnik.com/scenesse-implant-v...ami-florida.php
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seeva222
Posted on: Mar 4 2020, 04:26 AM


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Miami, Detroit and LA?

https://scenesse.com/public/epp-centers/
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seeva222
Posted on: Mar 3 2020, 08:03 PM


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Now someone needs to find UHC and Cigna.
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seeva222
Posted on: Mar 3 2020, 01:11 PM


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Wolgren. WTF is wrong with you? EPP patients can’t find info easily. Me while you’re fishing for cosmeceutical grants that you would get in one week of an EPP rollout.

Malfeasance.

  Forum: By Share Code

seeva222
Posted on: Mar 3 2020, 10:32 AM


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Avita involves abrating the skin and spraying new skin on. That’s pretty intense. . I see these as complementary
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seeva222
Posted on: Mar 2 2020, 08:42 PM


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At some point, even if it stays down, the market will start differentiationing between companies that will be impacted by the virus (cruise lines are fucked) and those that are less so,

Clinical has to be among the least impacted categories.
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seeva222
Posted on: Mar 2 2020, 02:07 PM


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Took out the last warrants

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seeva222
Posted on: Mar 2 2020, 12:50 PM


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CUV unaffected by corona
https://www.asx.com.au/asxpdf/20200302/pdf/...nrdc5tnbtyf.pdf
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seeva222
Posted on: Mar 1 2020, 10:04 AM


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They are no longer pursing nasdaq
  Forum: By Share Code

seeva222
Posted on: Mar 1 2020, 09:08 AM


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So why did he emphasize listing on the NASDAQ Only to retreat from that perspective? Meanwhile the shorts in Australia are hammering the stock.
  Forum: By Share Code

seeva222
Posted on: Feb 29 2020, 08:52 AM


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Would a Nasdaq listing quiet the short problem?
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seeva222
Posted on: Feb 28 2020, 01:30 PM


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The virus will have no effect on Clinuvel and balance sheets win in downturns. So, bargain prices for sure over the long term.

Short term? Who knows.
  Forum: By Share Code

seeva222
Posted on: Feb 27 2020, 01:42 PM


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They’ve also got the Baltic Sea covered.

These jokers just made inorganic growth one of their four pillars.

They can’t even get a map right... company integration absolutely blows as does the debt that comes with such an acquisition. Bad integration, imagines synergies and debt bring down most acquisitions.
  Forum: By Share Code

seeva222
Posted on: Feb 26 2020, 07:21 PM


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I want them to invest, but Where are the investments going? To the US roll-out? I’m all for a cosmeceutical play, but let’s scoop up the markets we’ve already made first.
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seeva222
Posted on: Feb 26 2020, 10:37 AM


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There are few better opportunity plays right now other than your mattress
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seeva222
Posted on: Feb 26 2020, 09:34 AM


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It’s actually one of the perfect stocks to buy as it’s a guaranteed annuity for an orphan indications so highly unlikely to get cut. Then you add in growth potential… What’s concerning is management is already thinking about in organic growth before they made any real money.


Get the rollout done PW
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seeva222
Posted on: Feb 25 2020, 01:23 AM


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Cramer sees biotechs as refuge

https://www.cnbc.com/2020/02/24/jim-cramer-...ven-plunge.html
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seeva222
Posted on: Feb 23 2020, 09:45 AM


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Sun tan threatens the coral reef

https://www.instagram.com/tv/B8367tYB0ii/?i...id=zsar04mdx61o
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seeva222
Posted on: Feb 22 2020, 07:06 AM


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Thanks for the translation! Very helpful
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seeva222
Posted on: Feb 20 2020, 07:34 AM


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And how many employees are on this mission critical task????

Imagine trying to get $100 million rollout underway while relying on a nonprofit to do all of your legwork?

How dumb would that make you?
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seeva222
Posted on: Feb 20 2020, 01:44 AM


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If you had cashed and bought Avita preapproval, you would have been down at the same point in time. Avita Went from 1.7 to 1.1. I went for that ride.

It didn’t start rising until March the following year.
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seeva222
Posted on: Feb 15 2020, 04:30 AM


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You’re on fire. Thanks
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seeva222
Posted on: Feb 14 2020, 03:26 AM


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How big is the market in Oz? Is off-label easier there? Seems to me this is a S/C drug waiting to happen D/U
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seeva222
Posted on: Feb 14 2020, 02:02 AM


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APF Facebook thread below.
  Forum: By Share Code

seeva222
Posted on: Feb 14 2020, 12:11 AM


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“At the earliest “

We all know how they work with timelines
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seeva222
Posted on: Feb 13 2020, 11:52 PM


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They told EPP patients it would be April at the earliest
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seeva222
Posted on: Feb 12 2020, 01:13 AM


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Here's the thing, despite the hamfisted manner in which this is rolling out, in spite of themselves, they're very quickly going to get to $100-million in revenue and then $200 and that's an annuity. Meanwhile they'll be chasing other indications with huge potential (vitiligo, DNA repair) and playing out the cosmesceutical path. I just don't understand the slow roll in the US, they should have had lists of patients ready to go.
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seeva222
Posted on: Feb 12 2020, 01:09 AM


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Exec Summary if someone wants to summarize the summary.

Executive summary
NEW DRUG APPROVALS AND LAUNCHES
A record number of new active substances (NAS) were
approved and launched in the United States in 2018,
bringing new treatment options to patients. Among
these 59 NASs, 27% are new therapies to treat cancer
and its symptoms and 20% are for the treatment of
infectious diseases. Almost half of these therapies
carried an orphan drug designation and over a third
of NAS launches were identified by the FDA as first-inclass, having mechanisms of action different from those
of existing therapies.

Translating a scientific breakthrough to the development
of a therapeutic medicine remains a slow process, with
the 2018 cohort of NASs taking a median of 13.6 years
from the time of first patent filing to launch. Still, the 2018
NASs launched approximately two years faster than
those in the prior two years. Among the 2018 new drug
launches, 12 drugs were launched more than 20 years
after their first patent filing, reflecting in some cases
drugs with older mechanisms of action being repurposed
and drugs that had previously launched globally but
not in the United States. Over two-thirds of new drugs
in 2018 came through the regulatory process under one
of several tracks intended to accelerate development
and review, but over the past three years only those with
accelerated approval and breakthrough status have seen
significantly shorter times from patent filing to launch.
Of the NASs launched in 2018, 46% were also approved
based on data from trials with fewer than 500 subjects
in total, as drugs types are increasingly specialty, niche
and orphan drugs, which typically enroll fewer subjects.
In addition, the amount of time a drug has been tested
in a patient population at time of approval — patientyears at approval — is declining.


The companies bringing these drugs to the market are
also changing. Emerging biopharma (EBP) companies
patented almost two-thirds of these new drugs and
registered 47% of them, while large pharma companies
patented one-quarter of the total. The critical role of
emerging biopharma companies in sourcing innovative
medicines has expanded significantly since 2010,
when they registered 33% of the drugs launched
that year. Although the importance of large pharma
in originating molecules is decreasing, they remain
important partners for EBP companies even as EBP are
increasingly able to commercialize alone. Large pharma
companies registered nearly half of the new drugs
in 2018, approximately half of which originated with
emerging biopharma companies.

CLINICAL DEVELOPMENT PIPELINE
As levels of life science investment continue to grow, the
pipeline of therapies still under development similarly
has been expanding. The number of molecules in latestage development now totals 2,891, increasing 11% in
2018 and 39% over the past five years. Oncology drugs
increased in number by 63% over the past five years,
contributing over 40% of the total pipeline increase,
while the number of vaccines under development has
declined over this period by 4%. Pain and dermatology
drugs also increased over 50% since 2013 but represent
just under 6% of the total pipeline each. Therapy areas
that have seen the biggest increase in activity over
the past year are those focused on oncology, ALS and
other degenerative musculoskeletal conditions, rare
diseases related to the GI tract, and non-narcotic pain
treatments.

Next-Generation Biotherapeutics (NGB) including
cell, gene and nucleotide therapies — though they still
represent less than 10% of the total late-stage R&D
pipeline – have more than doubled in number over the
past three years, as these new approaches to treating
and curing diseases command growing attention and
investment. Three NGBs were launched in 2018, and
though fewer than 20 are now available to patients,
they reflect recent and growing advances and activity in
oncology, neurology and rare diseases.

EBP companies, active in the fastest growing areas of
oncology and orphan drugs, also accounted for 72%
of the 2018 late-stage pipeline activity, up from 61% a
decade ago. Large pharma companies have seen their
share of the pipeline drop from 31% to 20% over the
same period.

Investment in future medical innovation continued
to grow in 2018 reflecting confidence in scientific
innovation to tackle unmet health needs. Venture
capital firms invested over $23 billion in 2018, with a
record number of deals recorded, and the 15 largest
pharmaceutical companies recorded more than
$100 billion in R&D expenditure for the first time, up
32% over the past five years.

CLINICAL TRIAL ACTIVITY
The total number of clinical trials that started in 2018
similarly indicate robust R&D growth of 9% over the
prior year and 35% over the past five years. Most of this
increase is due to the number of Phase II trials, which
increased 26% in 2018 and 61% over the level five years
ago, driven by oncology and neurology trials. Clinical
trials across phases in GI/NASH and oncology have
increased significantly, up 42% and 27%, respectively in
2018, while trial activity in the other major therapy areas,
such as endocrinology and respiratory, has declined.

The composite progression time from the initiation
of Phase I clinical development for a drug until a
registration decision is reached was 12.5 years in
2018, up six months from 2017, and resuming the
gradual lengthening of progression time for all drugs
in development. The composite success rate of
clinical development from Phase I trials to regulatory
submission — based on the percent of drugs successfully
progressing to each next stage of development — fell to
11.4% in 2018, down from 14.4% in 2017, and was below
the average of 14% in the prior ten years. All stages of
clinical development saw declines in success rates in
2018, with Phase I and Phase III trial success both falling
by 7−8%. Success rates by development stage have all
generally been consistent over the past decade, with
2015 an exceptional year, when the composite success
rate exceeded 22%. While therapy classes and drug
types under development have changed during the
past decade, oncology has had slightly lower composite
success rates (12%) than non-oncology (14.1%).
To examine the productivity of the clinical development
process, a Clinical Development Productivity Index was
developed measuring trial success in relation to the
effort invested in trials. Applying this new metric across
trials in nine of the largest therapy areas showed that
productivity has declined overall from 2013 to 2018
falling 27% from 2013 to 2018, heavily influenced by
a decrease in productivity in Phase I of 55% over that
period, and declines in Phase III since 2016. Phase II and
Phase III trial productivity remained relatively stable
since 2010. Declining productivity in Phase I was driven
by declines in success rates of 7% and increases in trial
complexity (which includes numbers of trial participants,
eligibility criteria, research sites countries, and endpoints)
of 6%. In 2018, complexity rose due to increases in all
complexity elements excepting the number of trial sites
and countries. For instance, the number of patients
expected to participate in clinical trials across the nine
key therapy areas increased 10% over 2017 with growth
influenced by an increase of the number of patients in
Phase III oncology and neurology trials.
The notable successes and failures of 2018 have also
shifted our understanding of human science, disease
and treatment. Since 2008 in Alzheimer’s disease,
only one product received regulatory approval, while
86 other development projects were discontinued,
including four in 2018. In NASH, nine new drugs were
added to the late-phase pipeline as drugs with several
mechanisms continue to show promise in research.
There were also some notable failures in cancer,
including the IDO mechanism and some with PD-1s,
where other drugs had succeeded in the same tumors.
However, these were offset by the large numbers of
approvals and the continued flow of breakthroughs in
other disease areas.

DRIVERS OF CHANGE IN CLINICAL DEVELOPMENT
Eight key trends in technology, science and data use
are currently influencing clinical development. Their
impact on trial design and complexity, duration and
success was explored through the IQVIA Clinical
Development Trends Impact Assessment completed
by IQVIA therapy area experts. All trends were
considered to have a high likelihood of impact, with
the probability of impact ranging between 74–85%.
The timing of trends is similar with all trends reaching
their peak impact within 2.5–4.0 years.
Digital health and mobile technologies will enable
the capture of drug efficacy and safety data remotely
within the bounds of clinical trials, and are therefore
expected to improve patient safety, enable virtual
trial formats and ease site work burden. They will also
make it easier to capture patient-reported outcomes
(PRO), which are expected to shed new light on patient
experience, as well as drug efficacy and safety outside
the clinical setting, and lead to accelerated trial times
as endpoints shift.
The emergence of new data sources and analytic tools
are also changing clinical development. Curated realworld data (RWD) sources will be used to optimize trial
design, speed trials by aiding selection of investigators
and sites, and enable new trial designs – e.g. by acting
as virtual/synthetic control arms and supporting
pragmatic, adaptive and real-world evidence (RWE)
registry trial designs. On top of RWD and other big
data in healthcare, predictive analytics and artificial
intelligence (AI) are expected to identify new clinical
hypotheses to test, minimize trial design risks and
speed enrollment by identifying protocol-ready patients
or by predicting which patients have disease and may
be eligible for recruitment.

Shifts in the regulatory landscape were deemed the
most likely to have an effect on clinical development
with an 85% likelihood of impact across therapy
areas. Expected to improve the likelihood of success,
regulatory changes are expected to further the
adoption of precision medicine approaches, enable the
use of novel trial designs and endpoints and generally
provide means for accelerated drug approvals.
Changes in scientific advances – shifts in drugs types
being tested and biomarker test availability – are
next most likely to impact clinical development and
will affect greater than five therapy areas within just
2.5 years. Shifts in types of drugs being tested to
disease modifying drugs, targeted therapies and NextGeneration Biotherapeutics will improve efficacy and
success rates and accelerate development timelines,
but will require longer-term patient follow up. The
increased availability and ease of biomarker testing will
allow for novel trial designs like basket trials, and help
to narrow patient populations to those more likely to
see effect, resulting in improvements in efficacy, safety
and success.
Finally, the availability of pools of pre-screened patients
and direct-to-patient recruitment are expected to
facilitate trial recruitment, helping sites to hit accrual
targets, decreasing trial duration and leading to
accelerated market availability.

Many of the therapy areas with the most complex trials
will see impacts of these trends within three years.
At a therapy area level, GI/NASH, neurology and
cardiovascular trials are the most likely to see rapid
changes over the next several years with changes
resulting from nearly all trends.

MODELING FUTURE TRIAL PRODUCTIVITY
The Clinical Development Trends Impact Assessment
was also used to model the future expected impact
of each key market trend on clinical development
productivity across trial phases and the nine key
therapeutic areas. Results show that each trend will have
a differential impact on trial productivity, success and
effort across therapy areas in the next five years. For
example, biomarkers will have the greatest impact on
clinical productivity yielding a 34% average increase
across therapy areas and trial phases and the greatest
increases in success rates (+27%). Similarly, pools of
pre-screened patients will yield a high increase in
productivity of 29% on average by driving the largest
average declines in effort, at -11%.

Trends impacting productivity varied by therapy
area. In oncology, pools of pre-screened patients
will accelerate trial recruitment and biomarkers
will improve success rates, leading to productivity
improvements as high as 104% and 71%, respectively.
Biomarkers will also yield consistently high
improvements in productivity of over 45% across four
other therapy areas: GI/NASH, rare disease, neurology
and cardiovascular. In addition, oncology and
neurology trials will see approximately 30% or greater
improvements in productivity over the next five years
— the largest increases in productivity across therapy
areas — while respiratory will see the largest decrease in
productivity.

Along with biomarkers, neurology trials will see the most
significant impact from regulatory changes and digital
health. Respiratory trials, however, will only see positive
productivity effects from RWD and predictive analytics
– both derived from the growth in the use of big data
and its analysis. While trends vary in their impact
on productivity across phases, the most significant
productivity changes will occur in Phase II trials.
  Forum: By Share Code

seeva222
Posted on: Feb 11 2020, 06:58 AM


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Oh, I’m sure he’s getting his iggy on right now. As down as I am on management and their delayed distribution once US distribution starts happening then things will change.

In the meantime I challenge each and everyone of you to tell Donald Trump that he doesn’t have to have a spray on tan. He needs to make this available to the masses.

Trumps vanity could help us! https://action.donaldjtrump.com/president-t...dAaAjJsEALw_wcB
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seeva222
Posted on: Feb 10 2020, 07:13 AM


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Oh, I’m not selling. I believe the DNA repair and other indications will eventually make this worth our while many fold over. But, the amateur hour around distribution is just shitting money out the window and failing to close off the market where a competitor looms. That’s just dumb.
  Forum: By Share Code

seeva222
Posted on: Feb 10 2020, 03:23 AM


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I have no problem with the protocols - it will help us identify new indications. My Issue is the complete amateur no-investment rollout completely dependent upon the APF to do the legwork.

Every dollar spent earns you a multiple. Every day of delay is lost money.
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seeva222
Posted on: Feb 9 2020, 12:22 PM


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They’ll hire a real estate agent in California to execute the integration.
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seeva222
Posted on: Feb 9 2020, 11:30 AM


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CUV is looking to buy a company. I’m going to guess that none of them have had the pleasure of trying to integrate another company before.
  Forum: By Share Code

seeva222
Posted on: Feb 9 2020, 08:31 AM


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What a joke. Walnut needs to get operational religion
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seeva222
Posted on: Feb 9 2020, 03:36 AM


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So, just so I have this right. We have issues training doctors, getting insurance approvals, identifying patients and in getting product for a multi-hundred million dollar US EPP market and we have, maybe, one person in the US, yet instead of hiring in the US or contacting a consultant, we’ve hired a cosmeceuticals person in Singapore where our CEO lives (and where none of our current markets are)? That right?

It’s like we have mall cops running the show. BTW, I’ll bet they’re hording cash for an acquisition. If they’re delusional enough to believe they can run a company without people, they’re delusional enough to believe that they can integrate a company with an absentee CEO and no people.

Every month of delay means millions out the window. Hire a consulting firm with experience and get it done.

Apparently they’re waiting on the Non-profit APF to do all the patient legwork and four months later they’re still asking for names.

Tick tock, drip drop... money is lost every day of delay.
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seeva222
Posted on: Feb 8 2020, 10:55 PM


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LH, who sold out, is still posting?

Why?
  Forum: By Share Code

seeva222
Posted on: Feb 8 2020, 10:39 AM


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“With FDA requirements ... they will closely monitor each patient. Each dr. who can do the implant will also have many requirements.”
  Forum: By Share Code

seeva222
Posted on: Feb 7 2020, 12:38 PM


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Just a reminder that Recell was way down till March (when sales started), now it’s up 5x.
  Forum: By Share Code

seeva222
Posted on: Feb 6 2020, 01:12 PM


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“they do not have to buy back shorted stocks as long as they're part of the index.”

Thanks for finally explaining this.
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seeva222
Posted on: Feb 6 2020, 12:12 PM


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The MT-7117 short theory is simply implausible to me. LH has lost his. The fact that he's still posting here tells me all I need to know . Iggy sold out and then returned like the herpes virus. This is a higher level of Cimetide fever. If MT whatever ended up with half the EPP market, CUV would still be undervalued. And that assumes a lot. Even in a best case scenario for MT7, I don't see 360 pills that work through your organs vs. 1 systematic implant as much of a choice once the infrastructure for Scenesse is set up (Hurry it up guys.) .

All that said, why wouldn't you buy at ASX inclusion and sell a week later every single time?
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seeva222
Posted on: Feb 6 2020, 11:11 AM


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This occurred to me as well.
  Forum: By Share Code

seeva222
Posted on: Feb 5 2020, 11:23 PM


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The majority of the shorting has zero to do with that. I can’t imagine anyone panicked enough about this to risk shorting the stock that is just about to get US distribution . When US distribution happens the stock will pop up.I don’t expect earnings to be a huge driver because the stock is based on potential market size.
  Forum: By Share Code

seeva222
Posted on: Feb 1 2020, 03:57 AM


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Perhaps we can get our fictitious writer to blog about it
  Forum: By Share Code

seeva222
Posted on: Jan 31 2020, 11:51 PM


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Interesting movement underway in beauty

https://www.vogue.com/article/toxic-beauty-documentary
  Forum: By Share Code

seeva222
Posted on: Jan 31 2020, 11:27 AM


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Responsible for the development of natural-based (plant & bacterial) skin care active ingredients for L'Oréal Group premium brands such as Biotherm. My activities cover both R&D and product management.

R&D :
- Translate consumer wants and needs into R&D concept
- Identify new sources of biomolecules (biopokymers, amino-acids, proteins) for skin and hair applications
- Develop enzyme-supported extraction bioprocess; drive new material development from lab scale to industrial scale
- Study influences of skin care ingredients on skin microbiome
- Develop in-vitro skin model
- Attend international symposium and review publications

Product management:
- Catch new market trends at global level
- Assess market competition
- Provide source data for product line communication
- Develop product sales strategies and uphold commercial team in product launch
- Deal with critical regulatory affairs issues
- Review product specifications and market requirements for continuous quality improvement

Achievement: Patent WO2017114783A1
Carbohydrate fraction isolated from a clarified lysate obtained from a biomass of bacteria belonging to the genus Vitreoscilla sp.
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seeva222
Posted on: Jan 30 2020, 08:27 PM


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The cash receipts haven’t moved the needle the last few go rounds. They’re so tiny compared to the market cap
  Forum: By Share Code

seeva222
Posted on: Jan 24 2020, 06:02 PM


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And. Many cold weather areas are sunny. Denver(I believe) has more sunshine days than many southern cities.
  Forum: By Share Code

seeva222
Posted on: Jan 24 2020, 11:05 AM


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Europe involves govt agencies, this is insurers. CUV is throwing away $1.5 million a week. Can’t wait to hear again how thrilled they are to get FDA approval against all odds.
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seeva222
Posted on: Jan 22 2020, 04:30 AM


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What did cause the rise?
  Forum: By Share Code

seeva222
Posted on: Jan 21 2020, 08:04 AM


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I believe he has a balance sheet target. But that makes no sense in this case is every dollar spent would come back many times over.
  Forum: By Share Code

seeva222
Posted on: Jan 21 2020, 04:09 AM


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Every day they lose dollars: $250k a day, $1.5M a week, $7.5M a month.

*This assumes there are 1000 patients at 15K getting treatments every 2 months.

  Forum: By Share Code

seeva222
Posted on: Jan 17 2020, 06:21 PM


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It was written in obfuscation

Reminded me of my college papers.
  Forum: By Share Code

seeva222
Posted on: Jan 16 2020, 01:17 PM


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What does this mean?
  Forum: By Share Code

seeva222
Posted on: Jan 15 2020, 05:00 AM


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For you Aveda fans, the stock didn’t move until March the following year after approval in September. It just blew past $10 a share = close to a six fold increase in less than a year. If Scenesse starts getting distributed I would expect a pretty good run - though nothing close to Avitas because they never had the preapproval run up that Clinuvel had.
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seeva222
Posted on: Jan 15 2020, 12:28 AM


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Of course, we’ll likely miss most of that revenue this year and next because we’re not prepared.
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seeva222
Posted on: Jan 15 2020, 12:12 AM


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The math on that, at 6 implants a year, is pretty good. 1000 x 100k = 100 Mill in ARR
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seeva222
Posted on: Jan 10 2020, 12:33 PM


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Great incentive structure. Ugh. We’re still getting patient lists from the APF, could have done that years ago.
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seeva222
Posted on: Dec 31 2019, 05:24 PM


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To use recell you have to burn off the top layer of skin with a laser and then “spray on” your skin and let it regenerate.

Incredibly promising for many skin treatments, but a pretty aggressive way to treat Vitiligo. Scenesse for my body and face and avita for my hands is how I’m thinking about it
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seeva222
Posted on: Dec 31 2019, 12:31 AM


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Avita will be a complementary treatment.
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seeva222
Posted on: Dec 29 2019, 12:55 AM


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Back over 20 here in the US. Setting up nicely for a rally with so much on tap.

TGA
OTC
NICE
Rollout news
New indication
More Euro Centers
Vitiligo News
DNA Repair
Cash Receipts
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seeva222
Posted on: Dec 22 2019, 12:25 AM


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“The global Cosmeceuticals market was USD 45.47 billion in 2017 and is estimated to reach to USD 72.99 billion by 2023 at a CAGR of 8.21% during the forecasted period. The global Cosmeceuticals market is outpacing all other product segments in the personal care products and cosmetics industry.”

Now imagine if you had an FDA approved drug, with DNA repair ability and a brand of leader in photo protection?
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seeva222
Posted on: Dec 21 2019, 11:59 PM


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“The global Cosmeceuticals market was USD 45.47 billion in 2017 and is estimated to reach to USD 72.99 billion by 2023 at a CAGR of 8.21% during the forecasted period. The global Cosmeceuticals market is outpacing all other product segments in the personal care products and cosmetics industry.”
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seeva222
Posted on: Dec 21 2019, 01:19 AM


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That is awful
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seeva222
Posted on: Dec 20 2019, 05:43 AM


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28k globally is a pretty large number. 6k in Japan. If 3000 are eligible for treatment that's 210 million a year in Japan at 70k (and frequency might be higher)

XP patients have sun sensitivity, a 10,000-fold increased risk of skin cancer and defective DNA repair
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seeva222
Posted on: Dec 20 2019, 03:53 AM


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Xeroderma pigmentosum (XP) is an ultra-rare hereditary disorder, affecting an estimated 1 in 250,000 people globally. Those affected are particularly susceptible to developing actinic keratoses and squamous and basal cell carcinomas due to a defect in, or lack of, nucleotide excision repair (NER).

Learn more on XP here: https://zurl.co/3HMR

Holy crap.
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seeva222
Posted on: Dec 19 2019, 01:09 PM


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Have to agree. Scenesse was approved without restrictions, an implant that tans and forms a natural sun barrierer, could repair DNA and is a cash cow for an orphan disease (and possibly several). Good times should start rolling soon IF this team can execute.

Looking forward to rollout news, new indications and Vitiligo and DNA news.
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seeva222
Posted on: Dec 18 2019, 11:47 AM


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Rollout news will drive action. Did for Avita
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seeva222
Posted on: Dec 16 2019, 11:39 AM


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It does look like there have been holiday/new year rallies in the past
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seeva222
Posted on: Dec 14 2019, 05:23 AM


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Every dollar they spend on the rollout will come back to them quickly and many times over. It’s not like this is R&D that will take years to recoup. That money comes back immediately. I completely get fiscal conservatism, but this is immediate return.
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seeva222
Posted on: Dec 14 2019, 12:01 AM


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It’s not more convenient and keeping to a regimen like that is hard. Pills and creams are hard to keep up with.
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seeva222
Posted on: Dec 13 2019, 06:36 AM


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They need to stop patting themselves on the back for their tough road. It’s in the past, the game is on and they’re in the Super Bowl and they’re still talking about how hard it was to get to the playoffs. Yeah, it’s hard. It is for everybody.
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seeva222
Posted on: Dec 10 2019, 06:18 PM


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That would probably put the adult population at at least 2,500. > $270 AUD

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seeva222
Posted on: Dec 10 2019, 05:38 PM


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4,500 EPP patients in the US? Where did you see that?

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seeva222
Posted on: Dec 10 2019, 03:05 AM


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That graphic looks wrong. 40mm for EPP?
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seeva222
Posted on: Dec 10 2019, 12:59 AM


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If this does show progress for DNA repair what are the market implications?

Does this go to a broad-based market? Or will this just be used in high-risk situations?

Tx
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seeva222
Posted on: Dec 7 2019, 05:38 AM


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I’m going to guess these patents have taken some time away from the team, no?
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seeva222
Posted on: Dec 6 2019, 09:53 AM


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Anti-aging. That sounds like a pretty good market to me. :-)
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