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Yup did not get that big push like I thought we might get but damn almost 200 million shares. Good GOD!! MAN!!
I think next stop is $5.50 - $6.00 today into the close. I think we could get it
Thanks brotha!! VBIV the volume today WOW!!!!!!
Glad you are doing well on it. I still have shares from .83 and also happy.
VBIV the good news was put out yesterday. Their Covid data was very good. I was shocked that it went down yesterday to be honest. I think people had not really looked at it very well. Also there was some shorts trying to cover IMO yesterday. This is not going up due to the price target. This is just reacting late to the news.
Supposed to hear i think by end of year
Sad part is VBIV is my pick due to their hep b drung the covid drug is just bonus. Either way I think this stock is $8 soon. I think the down day today was for shorts to cover.
I think the wife has squash on her list next!
Actually my wife and I are growing some different herbs, watermelon, lettuce, cucumbers, peppers and tomatoes.
I am holding what I have here. Been so busy the last two days have not really had much time to look at the market.
ADMA tomorrow after trump to authorize blood plasma for Covid.
I agree SESN is at that point where anyone in is not selling. If any new shares are to be had they will need to take this higher. With the volume and the weekly chart I like this to really move into FDA action.
SESN just bought another 5K shares. That weekly has a nice inverse H@S pattern here. If we break 1.25 I think this one can find some legs.
No problem bro! VBIV is a serious long for me. I think they get approval on their sci b vac drug gets approval soon. Then not to mention their cancer drug has had good results so far.
Agree I think we are seeing some stop losses get triggered. I plan on riding it out there.
I just added some VBIV. I still like this one a ton. Lots of irons in the fire. Plus they will probably get approval on the Hep B drug.
Just added some BTG on this dip. Their earnings were block buster and they doubled their Divy. I like this dip.
I am holding my shares. The SAR flipped and I think its down on pretty low volume considering the volume the last few days.
I do not see any news so far. Its nice to see it moving!
VBIV IMO will be back to $6 soon.
Yup I am doing the same. It popped the SAR so I think we get some nice momentum here.
VBIV nice news out!!
Therapure Biomanufacturing Signs Manufacturing Deal With VBI Vaccines for Coronavirus Vaccine Candidates
BY Business Wire
— 9:04 AM ET 08/18/2020
MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Therapure Biomanufacturing, a division of Therapure Biopharma Inc., announced today the signing of an agreement with VBI Vaccines Inc. ( VBIV ) for the manufacture of their coronavirus vaccine candidates. Therapure Biomanufacturing is an integrated contract development and manufacturing organization (CDMO) focused on biologic and high value therapeutics that can provide new options for patient care. Under this agreement, Therapure will be responsible for the biomanufacturing of the vaccine drug substance as well as the aseptic fill of the drug product at the Therapure facility in Mississauga, Ontario.
Mr. Safa’a Al-Rais, Therapure’s Chief Operating Officer, said: “We are delighted to partner with VBI to assist with providing an effective response to the ongoing COVID-19 pandemic through Therapure’s biomanufacturing and aseptic fill finish services for VBI’s innovative COVID-19 vaccine candidates, which utilize their flexible enveloped virus-like particle (eVLP) platform technology. Therapure prides itself on its development, clinical and commercial cGMP manufacturing expertise providing solutions for biologic therapeutics and innovative drug delivery technologies, which make a difference in patients’ lives.”
“We look forward to working with Therapure to address the ongoing public health challenge,” said Jeff Baxter, VBI’s President and CEO. “Therapure’s proven cGMP biomanufacturing capabilities and expertise with aseptic fill finish make them a great partner as we advance our vaccine candidate into and through clinical studies.”
Yes it did hit it. Watch for a SAR flip at 4.45 and from there I think we are back to $6.
VBIV is starting to get jiggy here!
CPRX I like the company and feel it can go higher but have to say with them not getting approval on the label expansion. So really might take the loss on this one here and move it to another long I have. VBIV I am sticking with it here. I still like them.
VBIV is a solid play IMO. Granted it needs to consolidate here. I think it will go higher but it will take a some time.
I just bought another 5K shares of SESN. I like the way this one is trading. Plus it has had a ton of buying the last month. I think this one could be one of those plays that bust out to $3 soon.
VBIV so glad I bought back a good chunk of my shares yesterday. I figured it was time to jump back in.
It was not the end of the world. They are still selling their drug and still making money. Also about to launch in canada.
Yes I think they can see $2 pretty easy.
I dont think it fills it to be honest. Some gaps dont fill. This one should get word from the FDA soon on their Hep B Drug. I think it gets approved.
Sold the two mining stocks I had today. Looking at the charts on gold and silver here and they are due for a pull back. Gold alone has been up 12 days in a row. Its getting way overbought here. Picked up another position in ATRA on the pull back.
This is exactly why I think Analyst are useless.
Christine Brown- August 3, 2020, 6:10 AM EDTSHARE ON:
In a report released today, John Newman from Canaccord Genuity maintained a Buy rating on VBI Vaccines (VBIV), with a price target of $3.00. The company’s shares closed last Friday at $4.07.
Now how in the hell are going to put a buy rating on something when the stocks current price is trading above your new so called price target. This is the exact reason I never pay attention to price targets of analyst ratings. If its trading at $4 then your price target on the stock should be higher if your telling people you think its a buy. SMH!!
SESN imo is just getting started. We get that approval in the US and this one runs much higher.
There was talk yesterday that our gov is really considering using blood plasma from covid patients for a treatment.
ADMA is going to break out hard here. I think we could see 6-6.50 from here. The volume today was freaking huge.
They Had nice results on their bladder cancer drug. I think there is a good shot it gets approved. They are also doing a testing with their drug combined with one of astrazeneca's. I think they are looking to hear from the FDA by the end of this year or earlier.
Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
Sesen Bio Reports Positive, Preliminary Data Update from Phase 3 VISTA Trial for High-Risk Non-Muscle Invasive Bladder Cancer
August 8, 2019 at 4:01 PM EDT
PDF Version
Updated 12-month Phase 3 Data will Serve as the Basis for Submission of the BLA
On Track for Anticipated Initiation of BLA Submission in 4Q 2019
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 8, 2019-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported updated, preliminary primary and secondary endpoint data from the Company’s Phase 3 VISTA trial further supporting the strong benefit-risk profile of Viciniumfor the potential treatment of patients with high-risk,bacillus Calmette-Guérin(BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). The updated preliminary Phase 3 clinical data will serve as the basis for the anticipated initiation of the Company’s BLA submission in 4Q 2019.
“After two very positive meetings with the FDA in the second quarter, we are now focused on initiating the BLA submission for Vicinium in the fourth quarter under an Accelerated Approval pathway with Rolling Review,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “We believe this regulatory pathway and our strong 12-month Phase 3 data could potentially expedite patient access to Vicinium, which is particularly important in light of the ongoing BCG shortage. We look forward to our two additional face-to-face meetings with the FDA in the fourth quarter as we work to bring Vicinium to market to help save and improve the lives of patients with NMIBC.”
Phase 3 VISTA Trial Progress
Updated Primary and Secondary Endpoint Data from Phase 3 VISTA Trial Support a Growing Body of Evidence Demonstrating the Clinically Meaningful Anti-tumor Activity of Vicinium: In May, Sesen Bio announced updated preliminary data from its ongoing Phase 3 VISTA trial, a single-arm, 24-month, multi-center clinical trial designed to support the approval of Vicinium for the treatment of patients with high-risk, BCG-unresponsive NMIBC.The trial completed registration in the second quarter of 2018, with a total of 133 patients across three cohorts based on histology and time to disease recurrence after adequate BCG treatment (at least two courses of BCG with at least five doses in the first course and two doses in the second course). Primary efficacy endpoints consist of complete response rate and duration of response for patients in Cohort 1. Secondary efficacy endpoints include time to disease recurrence for patients in Cohort 3, and time to cystectomy, progression-free survival, event-free survival, and overall survival for patients across all cohorts. As of the May 29, 2019 data cut, updated preliminary primary and secondary efficacy data for each of the trial cohorts were as follows:
Cohort 1 Complete Response Rate, Evaluable Population
Time point
Evaluable Patients*
Complete Response Rate
3-months
n=82
39%
6-months
n=82
26%
9-months
n=82
20%
12-months
n=82
17%
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred within six months of their last course of adequate BCG.
*Response-evaluable population includes any modified intention to treat (mITT) subject who completed the induction phase.
Cohort 2 Complete Response Rate, Evaluable Population
Time point
Evaluable Patients*
Complete Response Rate
3-months
n=7
57%
6-months
n=7
57%
9-months
n=7
43%
12-months
n=7
14%
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred after six months, but less than or equal to 11 months, after their last course of adequate BCG.
*Response-evaluable population includes any mITT subject who completed the induction phase.
Pooled Cohorts 1 and 2 Complete Response Rate, Evaluable Population
Time point
Evaluable Patients*
Complete Response Rate
(95% Confidence Interval)
3-months
n=89
40% (30%- 51%)
6-months
n=89
28% (19%-39%)
9-months
n=89
21% (13%-31%)
12-months
n=89
17% (10%-26%)
Patients with Carcinoma in situ with or without papillary disease that was determined to be refractory or recurred less than 11 months after their last course of adequate BCG.
*Response-evaluable population includes any mITT subject who completed the induction phase.
Duration of Response: The median duration of response for patients in Cohort 1 (n=86) is 273 days (95% CI, 122-NA), using the Kaplan-Meier method. Additional ad hoc analysis of pooled data for all patients with Carcinoma in situ (Cohorts 1 and 2, n=93) shows that among patients who achieved a complete response at 3 months, 52% had a complete response for a total of 12 months or longer after starting therapy, using the Kaplan-Meier method.
Time to Disease Recurrence: High-risk papillary (Ta or T1) NMIBC is associated with higher rates of progression and recurrence. Therefore, time to disease recurrence is a key secondary endpoint for patients with high-risk papillary-only NMIBC. The median time to disease recurrence for patients in Cohort 3 (n=40) is 402 days (95% CI, 170-NA), using the Kaplan-Meier method.
Time to Cystectomy: The FDA guidance states that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy. Therefore, time to cystectomy is a key secondary endpoint in the VISTA trial. Across all 133 patients treated with Vicinium, >75% of patients are estimated to remain cystectomy-free at 2.5 years, using the Kaplan-Meier method. Additional ad hoc analysis of responders and non-responders for all patients shows that approximately 88% of responders are estimated to remain cystectomy-free at 3 years.
Progression-Free Survival: 90% of all 133 patients treated with Vicinium are estimated to remain progression-free for 2 years or greater, using the Kaplan-Meier method. Progression-free is defined as the time from the date of first dose of study treatment to disease progression (e.g. T2 or more advanced disease) or death as a first event.
Event-Free Survival: 29% of all 133 patients treated with Vicinium are estimated to remain event-free at 12 months, using the Kaplan-Meier method. Event-free survival is defined as the time from the date of first dose of study treatment to disease recurrence, progression, or death as a first event.
Overall Survival: 96% of all 133 patients treated with Vicinium are estimated to have an overall survival of 2 years or greater, using the Kaplan-Meier method. Overall survival is defined as the time from the date of first dose of study treatment to death from any cause.
Vicinium Continues to be Well-tolerated by Patients in the Phase 3 VISTA Trial: As of the May 29, 2019 data cut, in patients across all cohorts (n=133), 95% of adverse events were Grade 1 or 2. The most commonly reported treatment-related adverse events were dysuria (14%), hematuria (13%) and urinary tract infection (12%) – all of which are consistent with the profile of bladder cancer patients and the use of catheterization for treatment administration. These adverse events were determined by the clinical investigators to be manageable and reversible, and only four patients (3%) discontinued treatment due to an adverse event. Serious adverse events (SAEs), regardless of treatment attribution, were reported in 14% of patients. There were four treatment-related SAEs reported in three patients including acute kidney injury (Grade 3), pyrexia (Grade 2), cholestatic hepatitis (Grade 4) and renal failure (Grade 5). There were no age-related increases in adverse events observed in the Phase 3 VISTA trial.
Vicinium Regulatory Pathway Updates
Bulk Drug Substance from the Full-Scale GMP Manufacturing Run at FUJIFILM Met all Phase 3 Quality Release Specifications: In April 2019, the first full, commercial-scale GMP run was completed at FUJIFILM Diosynth Biotechnologies U.S.A., Inc (FUJIFILM). Release testing of the bulk drug substance has been completed and all Phase 3 release specifications were met, further de-risking the Company’s manufacturing technology transfer to FUJIFILM and the Company’s Analytical Comparability Plan.
Recent positive interactions with the FDA reaffirm the Company’s confidence in the regulatory and commercial pathway for Vicinium
Type C CMC Meeting held on May 20, 2019. In conjunction with the technology transfer of Vicinium production to FUJIFILM, the Company has reached agreement with the FDA on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time.
Pre-BLA Meeting held on June 6, 2019. The Company has reached alignment with the FDA on the regulatory approval pathway for Vicinium:
The clinical, nonclinical and clinical pharmacology data, as well as the safety database, are sufficient to support a BLA submission, and no additional clinical trials are necessary for a BLA submission.
FDA recommended submission under an Accelerated Approval Pathway and Rolling Review.
Per the official FDA minutes received post-meeting, the FDA stated that the pre-approval inspection (PAI) may be completed at the time of PPQ manufacturing, which the Company believes will further de-risk the CMC review timeline.
Expected Advisory Committee (ODAC) meeting post-BLA submission to review the benefit-risk profile of Vicinium, given there have been no product approvals in this indication in the past twenty years.
Key Upcoming Corporate Milestones:
Type B CMC meeting to align on the submission strategy of CMC Module 3.
Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium.
Initiation of BLA submission including nonclinical and clinical modules 1, 2, 4 and 5.
SESN I bought another 1K here today. Total of 5200 shares. This is on the 3rd wave leg up here. Its starting to flag at this 1.00-1.04 range. This one is going to rip sooner or later IMO and see $2-2.50
I agree 100%. Looking at the longer chart that dollar level broke the reverse head and shoulders pattern. We hold it here this one should move hard off of it IMO. Also look at the volume the last 10 days. It has been up there.
SESN nice reversal today.