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Holders from before August are butthurt i understand that - but you need new buyers to take the stock back up. Yeah its a kick in the teeth that we can buy at $1.2, get over it.
How are they big shots, where are they from?
Sorry but I dont. I do hope they are prepping for other indications whe we wait.
Any insight If the qilu trial could be used to avoid another trial? I know we will find out exactly the go forward is soon, just curious on your take
The drug works. Problem is scrutiny because of the Biogen brain bleed drug they approved in June. They have to do it by the numbers
I had someone at Merck look over the results - toxicology looks good
Been in for a year. I dont think FDA doesnt think drug is safe. I think its just protocols.
Hiring good ppl seems like a smart/positive move, no?
We’re you in this in August?
I wish I was in th know on that. Cannell is pretty sneaky hiring two big shots to head up the weak areas. Sorry cant guess. AVXL and AFMD is where you want to be now.
What are the chances they won’t need to run another p3 trial - just resubmit?
IMO, can easily return to $1.50/share. But could move back to $2.00 relatively quickly. Best of luck to the longs./ok2
Tommyboy will be out by 5 pm with a good spin on today's FDA meet. Let's cut thru the BS and find out if Vinncenium is still alive.
Yes. Oct. 29th.
Not after that AH news
is this friday meeting ?
Fasten your seatbelt. Will start to move higher, trend is up!/ok2
The company have hired Eun Jang, named the Senior Director (Analytical Services) and Cherie Kaefring, named the Director (Clinical Operations). These two have been brought in for their expertise and will address the chemistry, manufacturing and control issues identified by the FDA./ok2
Lots sold on the news, but equally, shares being scooped up quickly in today's trading perhaps in anticipation of perhaps some even better news in just over a week's time. Best of luck to the retail investors and the longs./ok2
Back to the buy the hype sell the news. The few days where it was able to break away from it's usual pattern and hold on news were shattered on the FDA rejection
If meeting scheduled for Oct. 29th goes well and the company is able to resolve outstanding issues with the FDA which I believe are mostly related to manufacturing, this goes much higher. Best of luck to the retailers and the longs./ok2
Yes this new meeting is on the manufacturing side. The drug needs more data for approval probably into early next year
Great accumulation! Daily RSI 58, Weekly 38. Oversold and great SS.
So their big news is Hey! we have a meeting. At least it's something I guess. Still months away from what we were all led to believe was a certainty a few months back
Not his first F up.
HA! Approved the next day
Maybe if Cannell gives them his resignation we move forward expeditiously.
8k out
Sesen Bio granted Type A meeting by FDA for Vicineum marketing application
Sesen Bio (NASDAQ:SESN) has added ~16.8% in the post-market after the company announced that the FDA has granted its request for a Type A meeting to discuss the issues mentioned in the complete response letter issued for the marketing application for Vicineum.
The Chemistry, Manufacturing and Controls (“CMC”) Type A Meeting is scheduled for Oct. 29, the company said in a regulatory filing.
Sesen (SESN) is also planning for a separate Clinical Type A Meeting in connection with the marketing application which is likely to take place in Q4 2021.
“….the company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union,” the company added.
In August, Sesen (SESN) disclosed that the regulator rejected its Biologics License Application (BLA) for Vicineum as a treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Don’t have to worry about the listing compliance for a while now lol
Yep, it was fun while it lasted!
SESN - Up again today and now it's up after hours today. Looking so much better!
Great momentum today. Let’s hope it continues with good news to report.
We have a little momentum today , FDA update soon, should be positive
Ya I’m pretty sure he didn’t want people to take his advice or he would have come in at a diffrent angle. He was the opposite of the to da moon crowed lol
I don't think it goes back $0.70 again.
I was also quietly watching this board. Perhaps, Cjski68's messages were not all necessary, but he predicted CRL right. If people paid attention to what he was saying, then they could sell their shares for around $6.00, got out, and made good profits. The price from $6 down to 70 cents is not small money.
Hi, so the story goes on and the SP may be stable now over $1. Fair valuation to book value should be somewhere around 1.70-1.80. Any good feeling?
thats correct, reason is they will choose the biggest claiming amount beeing the leader. Generally claims higher 100k are in their orderbook.
Good luck.HD
Pick any one of them, they are all shysters. Unless you are going to be the lead plaintiff, it won't matter anyway as all the suits get consolidated - that's why it is called a class action.
It's possible but they have 155 million raised for commercialization.
Shouldn't affect them too badly.
Anybody join the class action suit? Any recommendations who to sign up with?
Probably have to return the 1.5 mil to EU partner.
Such a cluster f$ck
There goes Europe for now. At least there's still Asia right...
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