AllINGUY
Posted - 36 minutes from now
$CADL
dirtysyrian
Posted - 16 minutes from now
$CADL this is the preverbal money shot
AllINGUY
Posted - 9 minutes from now
$CADL
dirtysyrian
Posted - 10 minutes ago
$CADL “not publicly specified”
Wow… trying to sound smart != being smart
dirtysyrian
Posted - 12 minutes ago
$CADL and here.. not hard @deporte1800 just requires knowing to click researcher view in trial sites which every fda trial is registered
dirtysyrian
Posted - 13 minutes ago
$CADL
dirtysyrian
Posted - 13 minutes ago
$CADL why do people post things that are moronic and easy to validate? If you do not understand how to use trial sites then do not invest in pharma
RickHuble
Posted - 51 minutes ago
$CADL Oh, this is why....
Breakout!!!!! Boomskie!
RickHuble
Posted - 1 hour ago
$CADL I feel we will see $17+ soon....why does this chart whisper 75-80!!...wow
deporte1800
Posted - 3 hours ago
$CADL In the Phase II clinical trials that Candel Therapeutics is conducting with CAN-2409 for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer, it has not been publicly specified whether there is an Independent Data Monitoring Committee (DMC) overseeing the data. Does anyone on the forum know if Candel Therapeutics implements adequate monitoring measures to ensure the safety and efficacy of its clinical studies in these two Phase II trials? Can anyone who speaks frequently with IR ask about this topic?
Phil7777777777
Posted - 4 hours ago
$CADL We do. Only we know all the specifics and we are focused on long term value creation for patients and shareholders. It was of strategic importance to the company to bring additional high-profile institutional investors on board, while our existing key investors continued to support us We are very pleased we achieved this. This is important external validation of the quality of our programs, especially the phase 3 trial success, that is expected to help with significant value creation in the short to intermediate term, while also increasing coverage. We are now entering the next, exciting phase of the value creation journey. This is about the long game, not day to day fluctuations in share price. does this suggest partnerships
ChatGPT said:
ChatGPTThe statement strongly suggests preparation for partnerships or significant collaborations, though it does not explicitly confirm them. This language likely indicates an openness to partnerships or strategic alliances.
deporte1800
Posted - 4 hours ago
$CADL Part 4. CAN-2409, developed by Candel Therapeutics, has received Fast Track and Orphan Drug designations from the FDA for the treatment of advanced stage pancreatic cancer and non-small cell lung cancer (NSCLC). These designations are intended to expedite the development and review of drugs for serious diseases with unmet medical needs. In Phase II clinical studies, CAN-2409 has shown promising results: Pancreatic cancer: In patients with non-metastatic pancreatic ductal adenocarcinoma (PDAC), a median overall survival of 28.8 months was observed in the group treated with CAN-2409, compared to 12.5 months in the control group. Lung cancer (NSCLC): In patients with progressive disease despite immune checkpoint inhibitor therapy, the median overall survival was 20.6 months after two administrations of CAN-2409 plus valacyclovir, compared with 11.6 months reported with standard chemotherapy in a similar population. The FDA's decision on conditional approval will depend on all the data.
deporte1800
Posted - 4 hours ago
$CADL Part 3. Odds based on historical data: According to FDA reports, approximately 10-20% of oncology drugs receive approval based on Phase II results, usually under the Accelerated Approval pathway. In oncology, 43% of accelerated approvals were based on tumor response criteria as an acceptable surrogate marker (FDA Annual Report). Conditions for advancing directly to confirmatory phase III: If the FDA does not consider the phase II data to be sufficiently robust for approval, it may recommend directly initiating a phase III trial with an adaptive or accelerated design. In these cases, confirmation of clinical benefit is expected to be obtained quickly due to the demonstrated initial efficacy. In summary, the likelihood of the FDA granting an accelerated approval based on phase II is higher in serious diseases (such as cancer) with clear and promising data. The key is to present convincing evidence of clinical benefit and to use well-validated biomarkers or surrogate measures.
deporte1800
Posted - 4 hours ago
$CADL Parte 2. Promising preliminary evidence: If Phase II data show strong results on measures such as: Objective tumor response (ORR): A significant improvement may justify approval. Progression-free survival (PFS): A notable increase over standard therapy. Validated surrogate markers: If there are clear biomarkers that predict clinical benefit, this strengthens the application. Robust Phase II trial design: Well-designed trials (randomized, controlled) with representative populations increase the FDA's confidence in accepting the data. Regulatory designations: Drugs with Fast Track, Breakthrough Therapy, or Priority Review are more likely to receive conditional approval.
deporte1800
Posted - 4 hours ago
$CADL Part 1. Very interesting, Candel may request a conditional approval if the results presented during the first quarter of 2025, continue to be spectacular in relation to lung and pancreatic cancer. Accelerated approval strategies: Promising preliminary results in phase II may be enough to request a conditional approval or to advance directly to a confirmatory trial. How likely is this to occur by the FDA? ChatGPT Plus The likelihood of the FDA allowing an accelerated approval based on preliminary results from phase II depends on several factors related to the disease, the drug, and the strength of the data obtained. Key factors that increase the likelihood of accelerated approval: Serious medical condition or high unmet need: Drugs for diseases such as certain types of cancer (especially in advanced or metastatic stages) are more likely to receive conditional approval, since the potential benefit outweighs the risks of incomplete data.
deporte1800
Posted - 5 hours ago
$CADL Very interesting... If the drug has received Fast Track designation? ChatGPT If a drug receives Fast Track designation. This designation, granted by the FDA, is intended to speed up the development and review of drugs that treat serious conditions and that meet an unmet medical need. Impacts of Fast Track designation on Phase II. Accelerated approval strategies: Promising preliminary results in Phase II may be sufficient to request conditional approval or move directly to a confirmatory trial. If clear benefits are seen (such as improved tumor response rate or progression-free survival), Phase II may be completed in less than a year. The speed with which endpoints are met (e.g., tumor response). . In short, Fast Track designation allows for faster progress in the development of a drug, shortening clinical phases and, in some cases, combining them to maximize efficiency.
claybridge
Posted - 9 hours ago
$CADL cleaned up nicely... highly recommended
claybridge
Posted - 9 hours ago
$CADL if this board were Survivor, I'd vote dirtySyrian the hell off the island! Lord.
dirtysyrian
Posted - 10 hours ago
$cadl I posted 3 of the past 4 approvals with tickers and stock charts.., this guy ran away like a little baby :-)
dirtysyrian
Posted - 10 hours ago
$CADL but no amount will matter because this little guy just wants to argue.., he’s cute
dirtysyrian
Posted - 10 hours ago
$CADL
dirtysyrian
Posted - 10 hours ago
$CADL 3 of the most recent 4 are lower post approval than the run up it would be 4 out of 4 but one was private
torotoro222
Posted - 10 hours ago
$CADL come on you people. Don’t you see price action?
torotoro222
Posted - 10 hours ago
$CADL NO 3 TICKERS NO NOTHING
dirtysyrian
Posted - 10 hours ago
$CADL I posted a full study Life is hard for this broken ego.. love how he uses all caps
dirtysyrian
Posted - 10 hours ago
$CADL have you all ever seen such a grifter?
torotoro222
Posted - 10 hours ago
$CADL IF THIS GUY DON'T GIVE 3 TICKERS THAT ACTED LIKE CADL AFTER SUPER PHASE 3 RESULT - HE IS FULL OF S*** AND YOU KNOW WHAT TO DO!! NO GOING AROUND, JUST 3 TICKERS! 3 TICKERS! NO BULL**** AROUND IT.
dirtysyrian
Posted - 10 hours ago
$CADL look at this guy