Durect (DRRX)

[whytestocks]

News: $DRRX Durect Corp (DRRX) Q2 2020 Earnings Call Transcript

Image source: The Motley Fool. Durect Corp   (NASDAQ: DRRX) Q2 2020 Earnings Call Aug 3, 2020 , 4:30 p.m. ET Operator Continue reading

Got this from DRRX - Durect Corp (DRRX) Q2 2020 Earnings Call Transcript

[whytestocks]

News: $DRRX DURECT Corporation Announces Second Quarter 2020 Financial Results and Update of Programs

CUPERTINO, Calif. , Aug. 3, 2020 /PRNewswire/ --  DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended June 30, 2020 and provided a corporate update. Total revenues were $25.8 million and net income was $14.3 million for the three ...

Read the whole news DRRX - DURECT Corporation Announces Second Quarter 2020 Financial Results and Update of Programs

[ClayTrader]

* * $DRRX Video Chart 06-25-2020 * *

Link to Video - click here to watch the technical chart video

[ClayTrader]

* * $DRRX Video Chart 05-12-2020 * *

Link to Video - click here to watch the technical chart video

[Runners123]

NDA filed, when ever approved this will be $25 over night

[Runners123]

Yep its a buy now

[wakeupdummy]

this is looking better and better for buy in
..about due.

[ClayTrader]

* * $DRRX Video Chart 02-11-2020 * *

Link to Video - click here to watch the technical chart video

[mitchgree]

lARGE PURCHASE OF STOCK BY A HOLDING COMPANY.

[turning stone]

I am anticipating failure from the FDA also but one never knows. Let's hope they do the right thing (but that would be unusual).

[zj3001]

The eta was April from what I was reading. And yes, it can come sooner. If approved, and based off price action and possible increase short position, this could rocket on positive news.

I think the current pps is anticipating failure.

I’m still in, just waiting.

[Jimmy Joe]

If this was a lock the FDA would have approved already. Should hear soon either way.

[minnps]

Any idea when the FDA makes a decision on Posimir?

[turning stone]

What a hell of a buying opportunity for those of you just getting involved.

[turning stone]

BUGGY should have been BIGGY. Finger slip

[turning stone]

Great day based on what took place yesterday. Very heavy buying to cover all the selling. We now wait for the buggy in June or July.

[minnps]

It would be interesting to see a comparison to Exparel. Properly used, Exparel makes the patients much more comfortable, even if they still use some narcotics.

[zj3001]

I completely understand where you are coming from. However the opium epidemic is a huge problem. If a doctor can prescribe this right off the bat and give a pain rating of six versus eight with the competition, why would that doctor risk putting that patient in addiction phase and risk a lawsuit of malpractice?

[BooDog]

Just my non scientific opinion... I would think POSIMIR® would need to clearly show a benefit to the patients. Enough so that it would compete against the SOC (standard of care). If it is, it would penetrate the market and make a profit. IT MAY get approved, but I'm not seeing it close in on the competition enough that surgeons would reach for it.

Like I said though, that's just my unscientific opinion.



Although the FDA considers the recommendations of the AADPAC, the recommendations by the panel are non-binding. The final decision regarding pending regulatory actions for a product is made by the FDA.

"We appreciated this opportunity to present an in depth overview of our POSIMIR data and discuss it with the committee," stated James E. Brown, President and CEO of DURECT. "We are encouraged by the support from a number of the Committee members. We continue to believe the data meets all of the regulatory requirements and that the weight of the evidence supports approval. We look forward to working with the agency as it completes its review of the POSIMIR application."

https://ih.advfn.com/stock-market/NASDAQ/durect-DRRX/stock-news/81550685/durect-corporation-announces-outcome-of-fda-adviso

Message in reply to:

The FDA makes the final decision. This vote is intended to give them guidance but they are free to completely ignore it if they choose (at least that’s my understanding). I don’t like the degree to which the fda committee members opposed. Not sure I get warm and fuzzies from this.

[DR. EVIL]

Understood. Thanks.

[yanquitrader]

The FDA makes the final decision. This vote is intended to give them guidance but they are free to completely ignore it if they choose (at least that’s my understanding). I don’t like the degree to which the fda committee members opposed. Not sure I get warm and fuzzies from this.

[zj3001]

Haha, you crack me up. I’ll take a bottle of Vodka either way.

[turning stone]

So I have a bottle of Champagne on one side of my desk and a crying towel on the other.. The champagne seems to be moving in my direction but it might just be my power of suggestion.

[DR. EVIL]

So a tie vote equals approval?

[yanquitrader]

6-6 vote to approve

[BooDog]

385 pages in this briefing...

https://www.fda.gov/media/134171/download



This is an excerpt from the corrections page of the briefing
https://www.fda.gov/media/134172/download

“The pivotal studies in inguinal hernia repair and arthroscopic subacromial decompression demonstrated efficacy on the primary endpoints of mean pain intensity (PI) on movement AUC over the time period 1 to 72 hours post-surgery (AUC72). However, the studies demonstrated only a modest improvement in mean pain intensity, of 1.1 to 1.3 difference above SABER-placebo treatment for AUC for pain 0 to 72 h using an 11-point pain scale. It is clear from the forest plots of studies from the development program that the same or similar surgical models showed inconsistent and modest efficacy. Therefore, the clinical meaningfulness of the results are uncertain.”

I didn't read all 385 pages.

[yanquitrader]

Not looking good, unfortunately.

[yanquitrader]

What do you read into this:

Ronald Litman (Chairperson of $DRRX Adcom) starting the clarifying questions.

"I am a bit taken aback as the sponsor has presented data this morning that is in contradiction or not included in the briefing docs"

[yanquitrader]

Let’s do this.

[turning stone]

Well here we go. Trading will be halted prior to 8AM and until the voting is over. Could be halted all day, I hope not don"t think my heart could take that. We shall see. BEST OF LUCK TO ALL US LONGS

[minnps]

Hello all. I am new to the board and actually bought DRRX years ago for its Posimir product. I use a lot of Exparel and was interested in an alternative. Exparel flat out works, but is spendy. $300 for 20mls. Enough to do one big case or 2 small ones. Basically, I use it 3 to 4 days a week. I am a little concerned with the drop when potentially good news is coming soon.

Maybe it is not considered a big enough market.

[turning stone]

I give it a 50/50 chance with just a touch to the negative only because I am the internal pessimist till I see the positive occur. Get my drift.
I have been burned on a number of my stocks trying to get FDA approval because of politics from larger companies not wanting the FDA to approve that of a smaller company. We shall see if the FDA will slap the face of one of their past members.

[Stockslayr]

Any thoughts about next week before 16th?

[turning stone]

Looks like volatility will be going nuts up to and probably through 1/16/2020

[turning stone]

I look at Tray Trader as a fraud that is only my opinion. He is out there just trying to sell himself. He is just driving around trying to sell cough medicine like in the olden days

[Jimmy Joe]

Would like another analysis from Clay Trader for recent action. Maybe today?

[zj3001]

Not much volume either

[turning stone]

Here is the word of the day






Durect shares are trading lower. Not seeing any company-specific news to justify the price action.

Jan 9, 2020 2:43p ETBenzinga Stock Analysis
Benzinga /b]

[ClayTrader]

* * $DRRX Video Chart 01-07-2020 * *

Link to Video - click here to watch the technical chart video

[turning stone]

AS WE CREEP BACK UP.GO DRRX

[ClayTrader]

* * $DRRX Video Chart 01-03-2020 * *

Link to Video - click here to watch the technical chart video

[turning stone]

I see this as a minor bump in the road. The true longs will see it as a hiccup.If Jan 16th goes south then and only then will I sweat a bit.

[ClayTrader]

* * $DRRX Video Chart 01-02-2020 * *

Link to Video - click here to watch the technical chart video

[hmuney]

As sad as it is to see missed money without setting a stop loss order, I'm still in the green. Crossing fingers for an amazing 2020. Happy New Year @turning stone!

[turning stone]

I would expect starting tomorrow after all the little worry warts pull out with their losses that the share price will again start back up in anticipation of the big news coming around the 16th.

[turning stone]

Let's hope for better news around the 16th.

[yanquitrader]

MW Durect to discontinue development of psoriasis treatment after results from Phase 2a trial

[ssp1965]

31% down premarket

[turning stone]

I think the folks at DURECT have done everything they could do. The difficulty will be that the FDA is as corrupt as our slobs in Washington. This means if the industry makes the move with the FDA Durect will fail again. They would have to step on one of their previous employees and that would be hard for FDA to do. I give it a 60/40 chance they will approve.

[hmuney]

What are your thoughts on POSIMIR? AdCom majority vote "yes"? Some holiday humor:

http://stocktwits.com/hmuney/message/188582985