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You spelled slam wrong.
Monday morning BAM! GLTY
Looks like it’s finally time...for better or worse
* * $OCUL Video Chart 11-30-18 * *
Link to Video - click here to watch the technical chart video
Heellloooo… echo,echo… This little piggy should pop soon. It has big high/low swings low cap. I've been in a couple years, long @ $8.00 not worried. BUT I do hope they won't run low on funds. GLTY
Nobody here in a while, ghost town. Glad for your post. This stock is finally moving. Good luck.
Elsewhere, someone posted this about OCUL which is pretty much on point.....
'OCUL is in the waiting room awaiting the delivery for the approval by FDA which has failed to deliver a healthy babe. A new father and mother could deliver the healthy child which could result a wealthy family life.'
Eyeing a slice of six coming on a sneeze
* * $OCUL Video Chart 07-12-17 * *
Link to Video - click here to watch the technical chart video
Anyone else think that the current manufacturing situation means that this company will be sold sometime within the next few months. Should be painfully obvious to the large institutional holders of OCUL that the pipeline is much more valuable in someone else's hands. Therefore, worth much more to the current shareholders then reflected by the current price.
Longs Relax! $4.04 - $8.21 in 12 days last year.
Don't let the pros steal your shares at these prices. Good luck!
cantor was wrong.....carry em
Everyone not short is about to get smoked #FDAREJECTION
Bye!
Hope you sell with a little profit at least!
* * $OCUL Video Chart 07-11-17 * *
Link to Video - click here to watch the technical chart video
Shorts are going to get smoked. 229k shares AH .... Oh BABY! Those shares I picked up in the low $6's are looking mighty fine
We shall fight on the beaches, we shall fight on the landing ground, we shall fight in the hills, we shall never surrender
Doesn't seem to matter, if you held over the weekend from 7.00 you're down another 5%.
Wish I could say $7.00! $8.00 oh well gl.
Not FDA news just Adam F posting a page from the 483 and writing a hit piece. He did his job I got back in at $7 this afternoon.
not so solid week here on not so solid FDA news.
Looking forward to another solid week here heading into FDA news
Green close to end the week...enjoy the long weekend
IF the market takes it down again below $9, I'll be a buyer. Really like this one long term and expect it will run a few weeks before the July date.
OCUL$ Expert :Ocular method to be used for most cataract surgeries,says JMP Securities JMP Securities analyst Donald Ellis says that a key opinion leader, Dr. Cynthia Matossian, expects most U.S. cataract surgeries to incorporate Ocular Therapeutix's DEXTENZA. Ellis keeps a $25 price target and an Outperform rating on the stock.
Read more at:
http://thefly.com/landingPageNews.php?id=2553211&headline=OCUL-Ocular-Therapeutix-analyst-commentary-
Sorry but are all OCUL manufacturing issues resolved. txs
July 17th PFUDA
Thank you for response. But they havn't got they ok yet. will be awhile. Not sure. thanks for info. gl
Stock was $10 fell to $7.50 off a 483 on lab inspection price correcting itself ahead of July fda decision.
Sorry to be lazy, but why did it jump last few days. thank you.
Yeah, it was a gift below $8 just a few days ago. Increased my holdings 35%.
Hit $9.80 today nice
Canter Fitzgerald says the manufacturing "items of concern are addressable and shouldn't delay the product launch...."
They reiterated their Overweight rating with a $35 price target.....
Seems like a buying opportunity here to me.
OCUL $8.54 +.92
Dane Leone, BTIG - Analyst [49]
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Okay. And just a last point on that is has something, since you called out the Regeneron partnership in the press release and on the call here, did something specifically progress forward in that development pathway over the last three months or since your last update?
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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [50]
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So it's hard for us to comment given that this is something that we have to collaboratively speak about. So we cannot make unilateral statements.
All I would say is that the relationship is progressing nicely. And they are continue to be very enthused about the progress that is being made and we have provided them with product candidates that they are in the process of testing and feel that that's going in the right direction.
CC Notes regarding 483
Eric Ankerud, Ocular Therapeutix, Inc. - EVP, Regulatory, Quality, and Compliance [8]
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Good morning, Ken, thanks for the question. FDA completed their re-inspection of our facility as part of the NDA review late yesterday afternoon. As Amar mentioned 483 was issued.
We were pleased during the re-inspection that the FDA investigator was able to confirm our corrective action plan from prior observations and indicated that there was no further follow-up necessary to close out those issues. This was a new investigator, not the same investigator from prior inspections, and their primary focus in the 483 relates to a particulate matter issue as part of our manufacturing process. The issue relates primarily to completion of an investigation that we have underway in regard to the particulate matter, solidifying specifications for in-process 100% visual inspection of our inserts as well as enhancing our operator training.
We feel quite comfortable that we have the situation under control. And we are preparing responses to the 483 as of this morning in anticipation of responding within 15 calendar days to the agency. In addition to the particulate matter issue FDA raised a couple of observations in regard to analytical method testing to be completed as well as some other issue related to quality oversight of batch records.
So in summary, we believe that each of the observations raised by FDA during this continuous improvement review of our fully developed manufacturing process are handlable and will be resolved in our response to FDA. We are also pleased that the collaborative nature of our NDA review has continued between the various offices of FDA, and we are marching toward that PDUFA date and expect that we can resolve the 483 issues in a timely manner.
Donald Ellis, JMP Securities - Analyst [11]
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Thank you and good morning guys. Regarding the 483s, will there be a requirement for a re-inspection?
And then my second question is regarding the C code pass-through. What gives you comfort that a pass-through code will be granted for this product?
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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [12]
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So I will let Eric answer the question on the 483. And then Andy, maybe you can weigh in after that on the commercial stuff.
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Eric Ankerud, Ocular Therapeutix, Inc. - EVP, Regulatory, Quality, and Compliance [13]
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As a result of the completion of the re-inspection yesterday afternoon there is no indication of a Andrew Berens, Morgan Stanley - Analyst [23]
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Is there anything in their observations that you think could delay the action date specifically?
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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [24]
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Nothing that we can currently see. I think these as you know probably 90%-plus inspections have a 483. The question is what are the nature of the issues in the 483.
We think these are resolvable issues. And we have responses some already prepared and some being prepared to address them in a timely fashion.re-inspection needed going forward.
And then I guess what specifically gives you confidence that it's not going to happen? Because it seems like there is a number of things that were brought up on this 483.
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Amar Sawhney, Ocular Therapeutix, Inc. - President, CEO & Chairman [33]
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Yes, because most of the issues that are brought up on the 483 are not long-term type of issues. These are quality system and methodology type of things that are to be addressed by modifications of training procedures, documentation and in one case a test method that is a relatively short-term type of a test method. But Eric can comment a little on that.
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Eric Ankerud, Ocular Therapeutix, Inc. - EVP, Regulatory, Quality, and Compliance [34]
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In addition to that we have commercial product in our controlled inventory. And that was something FDA was looking for as part of this re-inspection as a sign that we are ready to go for a commercial launch.
Why Ocular Theraputix Inc. Got Hammered Today
The FDA wants some changes at the biotech's manufacturing plant.
Brian Orelli (TMFBiologyFool) May 5, 2017 at 4:56PM
What happened
Ocular Therapeutix (NASDAQ:OCUL) is down 15% at 3:43 p.m. EDT after the company disclosed that the U.S. Food and Drug Administration had found issues at the company's manufacturing plant.
So what
The biotech is expecting the FDA to make a decision on the marketing application for its eye-pain medication Dextenza on or before July 19, but the agency won't approve the drug -- even if it thinks the clinical data justifies it -- until the issues are resolved.
At the end of the inspection this week, the FDA inspector issued what's called a Form 483, listing what the company has to do to fix the problems. A vast majority of FDA inspections result in a Form 483 -- the reviewers wouldn't be doing their job if they didn't find something that could be done better -- so getting one isn't a big deal; the only question is how long it'll take to resolve the issues.
Closeup of an eye
IMAGE SOURCE: GETTY IMAGES.
Ocular Therapeutix said it plans to respond to the issues within 15 days with its corrective action plans. On the conference call, management indicated that they didn't think the plant would need to be reinspected, and the Form 483 issues could be resolved by July 19.
Now what
While it doesn't sound like this is a major issue, investors are justified in assigning Ocular Therapeutix a lower valuation because the issue brings uncertainty.
The inspection of its plant this week was a reinspection to resolve a Form 483 from a prior FDA inspection. Those issues were resolved through this week's inspection, which should give investors confidence that the company knows how to deal with Form 483 issues.
Investors willing to take on the extra risk could be getting a deal at today's knocked-down price.
Back in at $7.50 todays drop in price is just too tempting.
Remember when Regeneron just posted 1Q17 Eylea Sales of 860+ Million Dollars...
Remember when they partnered with OCUL in December to develop a new, better, formulation of Eylea with OCUL's technology.
I do!
BUY RATING REITERATED
https://stocknews.com/news/ocul-btig-research-reiterates-buy-rating-13-pt-68652801/
Folks who are new to OCUL and may not know. Here are the details on partnership with REGN. REGN is at $382/sh and more than $1B cash
https://www.streetinsider.com/dr/news.php?id=12128415
Besides Dextenza, there is sNDA for new indication. Glaucoma trials are positive so far!!!! Massive undervalued play $$$$$
Dextenza and Glaucoma combined more than $11B market in US alone. This co will be bought soon may be before approval. Massive undervalued and huge upside coming....
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