whygeniusfails

71 posts

whygeniusfails

whygeniusfails

@whygeniusfails

Austin, TX Katılım Mayıs 2015
17 Takip Edilen47 Takipçiler
whygeniusfails
whygeniusfails@whygeniusfails·
$glsi My point was. Its not coming any later than what has been anticipated since December 22. Its not new info that the trial size was going to increase in size, number of events for interim, etc…..if anyone actually read the dec 22 press release or listened to prior calls. This was already implied and discussed. The shorts started this bear raid when they broke support out of the $20-$30 range last week and did a great job further sucking retail into it on yesterday’s very positive news. Especially with HR requirements now being 0.55! This will be a one and done on the 1st interim. And by the way. Who else recently achieved 0.55HR or 0.56HR (ADC) for the same patient population. Enhertu…44% reduction in recurrence, very toxic, but front line therapy for same patient population….and GLSI is immunity layer that you would add to an ADC or biologic such as enhertu. GLSI tracking to 80% and safety is much higher. However, you can see, HR target is essentially the same. FDA approval of this shows a very supportive regulatory environment. GLSI should have traded the other direction. Tripple digits. This should be at $1B market cap.
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BioPharm_the_Magnificent
BioPharm_the_Magnificent@crypto_biotech·
$GLSI The negative or muted price reaction today is much more about market (retail & shorts) misunderstanding and typical biotech volatility than any fundamental problem with the update. 4 slides. Beautiful opportunity to add. This will go over $100:
BioPharm_the_Magnificent tweet mediaBioPharm_the_Magnificent tweet mediaBioPharm_the_Magnificent tweet mediaBioPharm_the_Magnificent tweet media
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whygeniusfails
whygeniusfails@whygeniusfails·
Thats where i think you guys are wrong. They doubled the size of the trial and they doubled enrollment. So thus, interim going from 14 to 28 was mostly expected. So the trial duration might be slightly lengthened but the number of events is also doubling…since Q1, non-hla have been getting randomized in blinded arms. I see 24 x events a lot sooner than market expects. I also think they might have passed the 14 x events already….they just increased their chances to get to 85% success on 1st interim….$10B TAM!….this should be $1B+ market cap. Drug works. And approval likely hood is very high on 1st interim. This was the right call. They doubled the TAM, didnt increase the length of the trial by much since events are doubling, increased approval odds SUBSTANTIALLY on interim.
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Jackson
Jackson@actionjv2020·
@ChartLearning @crypto_biotech 100% , while the chance of success increased substantially, they just added 1-2 years for interim result. We need a partnership for the rest of the world prior to interim result.
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whygeniusfails
whygeniusfails@whygeniusfails·
$GLSI he just cemented in back up plan. I think is still hits HR of 0.2….but, if he needs cushion he is still enrolling to ensure even at 0.55 the drug will be approved by US and Europe. Company did exactly what they said dec 22 but cleared the path for approval if needed with much higher HR….market isnt understanding this imo. But it will…..
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whygeniusfails
whygeniusfails@whygeniusfails·
$GLSI all this did was significantly reduce trial risk. I think it will be one and done at 1st interim…..but this hedges incase he needs lower p value….allows randomized arms to continue to enroll past 500…..market will wake up to see this is a HUGE win. If not, big pharma will. 85% success in 1st interim…..read the release carefully. Higher on 2nd. How do you think he calculated 85%….triangulated the data. Wake up. lol
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whygeniusfails
whygeniusfails@whygeniusfails·
$GLSI trial derisked significantly…HR ratio went from 0.3 to 0.55 in new protocol…increasing probability of success on first interim from 20% to 85%. Regulators made this one as much as a slam dunk as possible. Wow. Cashburn also half of what most expected in Q2. Only $2M. Very nice.
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Bryon Franzen
Bryon Franzen@bkfViking123·
$glsi .. raise coming?
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whygeniusfails
whygeniusfails@whygeniusfails·
$glsi smarter money is going to step in here….
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whygeniusfails
whygeniusfails@whygeniusfails·
(Con’t) Enhertu validates the value of preventing HER2 recurrence, while GP2 i believe will eventually become the low-toxicity immune maintenance layer added after increasingly effective frontline regimens. If GP2 eventually demonstrates: * strong hazard ratio reduction * durable immune memory * very low toxicity * compatibility with evolving HER2 regiment Enhertu is being positioned for other her2+ cancers which opens the door for GLSI as they now have an anti body to attach to……. GLSI is acquisition worthy……I would not be surprised here to see an acquisition or partnership…..
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whygeniusfails
whygeniusfails@whygeniusfails·
$GLSI The FDA approved Enhertu (trastuzumab deruxtecan) on May 16 for both neoadjuvant (before surgery) and adjuvant (after surgery) treatment of HER2-positive early breast cancer. The approval is based on the Phase 3 DESTINY-Breast11 (neoadjuvant) and DESTINY-Breast05 (adjuvant) trials. Enhertu is co-developed by AstraZeneca and Daiichi Sankyo and is already the world’s leading ADC franchise. Trial included High risk patients. But the FDA gave them both high risk and moderate risk even without moderate risk patients in the trial. This is pretty uncharacteristic. This approval is actually highly relevant to Greenwich LifeSciences and GP2/GLSI-100 because it reinforces a broader industry shift: HER2-positive breast cancer is increasingly being treated as a long-duration, layered, curative-intent continuum — not just a single-drug episode. Even approvals for patient populations not in the trial get a nod. All of this is potentially very very important for GP2. Here’s why. ⸻ The Big Strategic Shift Historically, HER2 treatment evolved like this: 1. Surgery + chemo 2. Add trastuzumab (Herceptin) 3. Add pertuzumab 4. Add Kadcyla in higher-risk residual disease 5. Now add ADCs like Enhertu even earlier The field keeps moving: * earlier * more aggressive * more personalized * more immune-focused * more recurrence-prevention oriented Enhertu entering the adjuvant/neoadjuvant setting validates that: * preventing recurrence in HER2+ disease is commercially enormous * regulators are willing to approve intensive therapy in curative settings * companies can generate multi-billion dollar franchises from recurrence reduction alone That directly supports the importance of the disease space GP2 is targeting. ⸻ Why GP2 Is Conceptually Different Enhertu: * cytotoxic ADC * kills tumor cells directly * very powerful * but also carries meaningful toxicity * generally finite treatment exposure GP2: * peptide immunotherapy * attempts immune surveillance against HER2-expressing residual disease * designed for long-term recurrence prevention * potentially much lower toxicity profile * more analogous to “immune maintenance” So the mechanistic role is different. The Most Important Implication for GLSI The market is now validating that: * spending huge amounts of money to reduce HER2 recurrence risk is acceptable * physicians WILL use aggressive therapy in early-stage disease * payors WILL reimburse expensive prevention-oriented treatment * regulators WILL approve therapies based on recurrence reduction endpoints That massively derisks the commercial logic behind GP2. Five years ago, people could argue: “Will anyone really use an additional therapy after standard treatment if patients already look cured?” Now the answer is clearly: Yes. Absolutely. The field is already doing that. ⸻ Why This Could Actually HELP GP2 Positioning Ironically, more intensive frontline therapy can increase the attractiveness of a low-toxicity immune maintenance approach afterward. Because clinicians worry about: * cumulative toxicity * neuropathy * cardiotoxicity * marrow suppression * tolerability fatigue * long-term survivorship quality If a patient finishes: * chemo * trastuzumab * pertuzumab * maybe Enhertu/Kadcyla …then a relatively benign immune booster strategy afterward becomes easier to justify conceptually. Especially if recurrence rates remain non-zero. ⸻ GP2 May Also Benefit Scientifically There’s another angle people are missing. ADCs like Enhertu may actually: * release tumor antigens * increase immune priming * alter antigen presentation * potentially synergize with immunotherapy approaches The oncology field increasingly believes: * targeted killing + immune activation together may be superior So future HER2 treatment paradigms evolve toward: 1. Tumor debulking/intensive eradication 2. Long-term immune surveillance maintenance That second category is exactly where GP2 sits. (con’t)
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whygeniusfails
whygeniusfails@whygeniusfails·
$GLSI a bit of a coordinated attack. Finished going thru 10k. Nothing to note other than efficient use of the ATM. They shook the tree a little…run to $40 soon is my prediction.
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whygeniusfails
whygeniusfails@whygeniusfails·
@bradloncar @BiotechTV $GLSI …FDA approved Enhertu (trastuzumab deruxtecan) on May 16 for both neoadjuvant (before surgery) and adjuvant (after surgery) treatment of HER2-positive early breast cancer” Clear signal from FDA, medical community, patients…to drive recurrence rates to near zero.
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whygeniusfails
whygeniusfails@whygeniusfails·
$GLSI steady grind up. Hasnt been this squeezy since last nov-dec…..next leg up to $45. Surprised to see it still in the $20’s…not for much longer.
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whygeniusfails
whygeniusfails@whygeniusfails·
$glsi Technicals look as solid as it gets.
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whygeniusfails
whygeniusfails@whygeniusfails·
$glsi this is just what they do. Their are air pockets on both sides of the trade. This is where they take retails money. Reminds me of the oklo trade this year. Went from sub $10 to $50….then they took it back to $19 before they accumulated andran it back up to $80…then $100+.
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