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Yeah. I believe it's just the overall market in general. Seems most small-cap bios have taken a beating this week.
I'm holding long. I actually added 4k shares yesterday. I'm holding approx. 60k shares. I picked up the majority of my shares earlier this year between 0.32 and 0.50 so I would like to hold at least one year. I believe positive NASH results and the court trial results in February should really propel the stock price. What about you?
This BS with the FDA is f'ing insane.
I would refer you to Lipocine's most recent investor presentation on their website for market value. After far as Clarus, they are already in litigation with Clarus of patent infringement. Most of the cases so far have been in Lipocine's favor. I can't remember when the final decision will be made.
Well, that would certainly be better than another CRL. I don't see Clarus' exclusivity being an issue. I believe Tlando being fixed dose while Jatenzo requires titration will be the difference. That's just my opinion. Jatenzo's exclusivity is based on the following taking from the Exclusivity Summary (link below):
https://www.fda.gov/media/138223/download
The determination is consistent with FDA’s decision to recognize exclusivity for other testosterone replacement therapies that have received exclusivity in the past based on the same general study design (a phase 3 study with a primary efficacy endpoint of the proportion of treated subjects with a T Cavg within the normal range after dose titration was complete).
Still, nothing's changed since Friday. Hope to hear something positive sooner rather than later!
I would put the odds at 75-90%. You never know with the FDA.
Yep. This pullback is healthy and was expected. Also, options expire this Friday with max pain of $2.50.
Me too!! Less than two weeks remaining.
A partner to commercialize Tlando. It will cost to hire and pay a sales team, it will take time and money to provide sufficient marketing, etc... A partner could handle the financial and commercialization aspects of all this and receive a small percent kickback from eventual Tlando sales. Makes sense to me.
I agree that a partner is likely since they do not have a sales team that I know of. I believe they established one prior to the first CRL but had to eliminate it to reduce costs and focus on correcting the issues identified in the CRL. I haven't seen anything since then about any sales team.
Finally broke through that.
Wrong. My current XR prescription is manufactured by Teva.
I don't know the answer to your question but I believe many (including myself) are expecting approval given the fact that Clarus got approval of Jatenzo with similar secondary endpoints and a worse safety profile and the fact that the FDA didn't ask for additional trials.
My mistake..... that should be Teva/Actavis.
Thanks for the reply. I did not know this and will do what you recommended. I'll report back once I find out. Thanks.
Just got my Adderall XR prescription refilled from my local CVS..... the manufacture is listed as Teva/Epic.
That's right! Hopefully, it works out for us this time. I've been here since December of 2014.
LOL!!! I'm pretty sure you're kidding but let's hope that doesn't happen!
My average in 1 account is about the same. In a separate account, my average is around 0.92. I have a third account with an average of over $9! Around 70% of my shares are under $1.
I currently pay $80 per month for my 15mg XR. I'll check who the manufacturer is.
I'm not sure how to interpret this question. It's all relative. Some purchased in the 0.30s. Others purchased at much higher prices that I'm sure will make their money back in the next few months.
I think it is very good news and also thinks it played a role in the LPCNs most recent CRL. Why would Clarus get its product approved while missing a few of the secondary endpoints and then petition the FDA not to approve any other oral T medications if they miss secondary endpoints? It makes no sense to me.
Here is a conversation starter:
https://www.regulations.gov/document?D=FDA-2019-P-4644-0039
PDUFA date is 11/9/19 but the FDA could announce decision prior to that.
No problem!! I'm liking the slow pps increase!! PDUFA date right around the corner.
TLANDO is twice a day, not three times a day.
I agree. I don't think it will run up to as high as it did in the past. That was a roller coaster. I rode that from $3 something all the way up to near $19 and back down to where we are now.
You may be right but I would think the runup would come closer to the PDUFA date. I hope it continues. Are you invested in ATRS too? I have sizable positions in both. Holding this one for 6 years or so now. I've owned ATRS for 1.5 years. I like them both.
That's incorrect. It would be for the twice a day pill as confirmed in the dose validation/flexibility study.
I think TLando is holding this back. Once it gets approved, that will validate the Lipral technology once and for all.
I think Adam shorts every Bio that pops hard like LPCN did yesterday. A bio will pop, Adam will post something negative, and boom the stock goes down. Anytime Clay trader or Adam posts about a stock, it goes down.
I'm guessing the approval of Xyosted was already baked in to the price. When product is launched and sales are being made, I believe the stock price will rise substantially.
LPCN is already very low right now. If the ABPM an phelbotomy studies are positive, I think the stock price will increase a great deal from where it is now. There is just so much uncertainty right now with those two studies going on.
ATRS does not have a lawsuit with LPCN. You are thinking about Clarus.
OK. I must have confused you with somebody else. I'm in SC so that was why I was asking.
gi, I may be wrong but didn't you tell me that you are from/live in South Carolina?
I was wrong. My average is $2.37 in my largest account, $3.26 in smallest, and around $7.50 in my medium sized account.
My average is $2.37 in my smallest account and probably $7.50 or more in my two largest accounts.
From Bob over on Yahoo message board:
I don’t have any new news as such but on,y confirmation that LPCN is still seeking partnership for PTB pill into phase 3. I don’t know of the progress as such but it’s on going, and could surprise us anytime. Secondly they are are also looking into early stage opportunities perhaps with L’ipral or in some other shape or form with existing pipeline. This comes direct from someone inside LPCN.
I agree about LPCN being a potentially extremely valuable stock especially at these prices.
Remember, if phase 3 is going well for PTB, the FDA could potentially allow them to start selling the drug so long as phase 3 continues with positive results.
I'm not sure where the once a day pill is time or trial wise. They haven't said anything about it recently that I recall. All I know is, once they have the 3 a day pill approved, the once a day should be easier.