Khedezla has unproven and unknown revenues. Par Pharma launched it late last year. Did Par Pharma give up rights to market the drug or will Par still sell Khedezla after Pernix launches it? If Par gave up rights, maybe revenue was not so good. It remains to be seen how much revenue Khedezla can generate. My first impression is it has a hard to remember name and probably will have a difficult time taking market share. It has to compete against Prestiq and I think there are two other bioequivalent drugs like Khedezla. Also, it has to compete against other ADHD drugs. So I just recommend not falling for the hype that the market size is around $700 million for branded Prestiq. Pernix plans to sell Khedezla as a cheaper alternative to Prestiq.
Interesting PTX is holding up well. I sold off the other half of my shares, so I am out for now and not sure if I am coming back in unless stock drops.
VTUS should license commercial ready products with $20+ million cash. I would like to see VTUS build a portfolio of commercial-ready specialty pharmaceuticals instead of spending tens of millions on development, even if it is on 505(b)2 accelerated approvals. FDA made VTUS do a second phase 3 for analfissure drug so it was not very accelerated, and VTUS spent a lot of money to do a second phase 3.
optional_options, are you in a stock basher boiler room or something? VTUS has over $20 million in cash so you are just posting nonsense.
I was just making a light-hearted observation. VTUS can only go down another $1.25. Yes, I like VTUS since it is selling close to cash value. I think Monday, 3/31/2014, is the last day to file 10-K, since that would be 90 days from end of quarter. Anyway, seems to have a lot of selling pressure since VTUS is one of the largest decliners since the beginning of 2014. It is down over 60%.
Protalix should switch to NASDAQ. Few biotechs trade on NYSE. So do you think listing on NYSE has helped or hindered Protalix's stock? I think it has hinders visibility since biotech traders might look at various lists of NASDAQ stocks, such as most active, largest gainers, largest decliners, new highs, new lows, and never see Protalix since it trades on NYSE.
Biobetters are those that like to bet on biotech stocks. Just kidding. Protalix has biobetters. Biobetters buzzword is not as popular as biosimilars buzzword. Biobetters are improved versions of biologics while biosimilars are similar and interchangable biologics. Biobetter development time and cost fall somewhere between biosimilars and a completely new biologic.
PLX recent annual report mentions the word "biobetters" 3 times. Pipeline looks like mostly biobetters. Pulmozyme drug seems to be a biosimilar since it has same indication and delivery mode. Oral Anti-TNF is a biobetter since it has a different delivery mode. If Protalix makes an injection Anti-TNF, that would be considered a biosimilar.
There is the 2010 BCPI Act (Biosimilar Price Competition and Innovation) that is suppose to speed up approval process for biosimilars and biobetters. I would like to see Protalix grow into a mult-billion dollar biobetter and biosimilar biotech, but their pipeline sure is going slow. Protalix needs partners, partners, partners to speed things up.
I attribute my PTX profits to mostly luck. I foolishly bought last year around $2.20 after that spike down under $2.00. Company was in big trouble up until the new management and new credit a few weeks ago. Anyway, it remains to be seen how long PTX takes to turn around. New CEO has a good track record, so I assume it will turn around. Only question is how long. I sold half my shares since PTX doubled.
VTUS looks like it is not going anywhere fast until FDA meeting. I hope company can file NDA with only one Phase 3. Filing NDA soon is main reason why I bought VTUS around $1.40 and also because it is relatively safe since company has around $20-$30 million cash. There is a chance FDA will make company redo second Phase 3. A similar drug, Rectiv, only used one Phase 3 under 505(2)(b). I do not know why FDA made VTUS do a second Phase 3.
But if FDA does not allow VTUS to file NDA now, I think VTUS will burn through that cash within a year. With $20-$30 million cash, VTUS could do like PTX and license some commercial ready drugs instead of trying to develop the other drug that is left in pipeline. I suppose it depends on direction CEO wants to take. GALE stock also did something similar by licensing the drug Abstral to try and generate some cash flow.
10-K says Aviezer's 2013 salary was $527,672, including bonuses he was compensated $1.77 million. The rest of top management all get paid between $230,000 to $302,000, including the bonuses, they made $600,000 to $1 million. Anyway, hope they can get partners to speed up development of other drugs and drug classes such as "enzymes, hormones, monoclonal antibodies, cytokines and vaccines."
VTUS short attack in last 10 minutes before close. Short volume average 40% last 8-9 trading days. Wonder if someone is day trading or building a longer-term short position.
VTUS might consider licensing some commercial ready drugs. Unlikely, but it is an option since they have $20-$30 million cash. Obviously, getting drugs to market quickly is one of the goals since they pursue 505(b)(2) NDA, which relies on existing drugs and is quicker than full NDA, pathways for their drugs.
VEN 309, iferanserin, is serotonnin antagonist. How about CNS (brain) indications? If Ventrus still owns all rights to iferanserin maybe they can out-license it to see if it has any CNS applications. It is a 5HTA2A and 30% 5HTA2B antagonist, with little 5HTA2C.
Protalix trades on TASE, Tel Aviv Stock Exchange, and was up a couple of percent. Also 10K is estimated to be released soon. Also I think it was close to breaking out.
Rectiv, nitro glycerin ointment, for analfissure used 505(b)(2) NDA, submitted one Phase 3. It got approved in 2011 after failing to get approval under another company which pursued 505(b)(1) full NDA, and submitted two or three Phase 3 trials. Hope Ventrus is studying Rectiv approval documents. Obviously, Rectiv is how Ventrus got the idea for their drug. Ventrus' cream is also a vasodilator.
Inasmuch as a primary purpose of this second Phase 3 trial was to complete the safety data package. That was last paragraph of the Feb 12, 2014 press release for second Phase 3 trial. My interpretation of that statement is that company thinks it can file 505(b)(2) NDA with present trials. The question is why FDA required second Phase 3 trial for 505(b)(2) NDA back in 2012. Did FDA want more safety data or more efficacy data or both?
inglebertney826 wrote: "Still going know where fast." Should be "nowhere" I think. In that case, you should COVER YOUR SHORT.
PLX has valuable platform and stock is a value in the biotech space. Pipeline is slow going and not too exciting on the surface.
Back in AUG 30, 2012, at pre-NDA meeting, FDA said second Phase 3 for VEN 307 was required. Might have to redo trial. I did not know FDA required Ventrus do a second Phase 3. Usually, 505(b)(2) is a shorter approval path and one Phase 3 is sufficient. Two Phase 3 trials are required for a full NDA under 505(b)(1).
I think second Phase 3 had similar results to first except for high placebo effect. Do not know if FDA will accept that. The safety data is usable. We will see at the future pre-NDA if FDA requires more efficacy data.
"CRLs on 2/12" VTUS reported results for second Phase 3, and did not get a CRL. For 505(b)(2) approval pathway, one Phase 3 clinical trial is enough. So FDA might let company file NDA. We will see as company is requesting pre-NDA meeting. Hope your VTUS "paper losses" come back. I just bought today as it seems like a good gamble that NDA might get filed.
And im_eating_burgers kisses mitch2bdog's butt a lot. Mitch = im_eating_burgers.
mitch2bdog was saying he warned last Monday that DARA had an ace, and implying DARA already knew of ODD granted last week. Also, im_eating_burgers said some investors knew last Friday since the granted date is 2/21/2014.