OK...good exercise before one turns in for bed I guess...lol!
1. Unmet medical need for this drug? Somewhat of an exaggeration frankly. The drug it was compared against, Zyvox, in the non inferiority studies, is marketed by Pfizer and has been out on the market for some time. The trial comparisons were very close. Dalb offers a once per week IV formula, while Zyvox is oral, or IV form, and must be taken daily. Think ours, being outpatient and once per week, is more convenient, thus gets the patient out of the hospital sooner, which is good for both the patient, and the hospital. I would prefer ours to be a once per week oral formulation which would be even better IMHO. Maybe in time.
2. Vote by ADCOM was unanimous but so was the Trius (CBST) antibiotic that came before ours.
We still had some labeling issues and probably some post approval safety monitoring, because of potential
liver issues. Ours is not for pediatric use or pregnant women. No studies were done with either children or PG women.
3. Have no clue.
4. Lots of small companies out there that remain small...LOL Not sure I understand the point.
5. Refer to above. If the implication is DRTX could be a target, then I agree
6. Low float simply makes the stock more volatile up, or down. What's the point?
7. Earnings are irrelevant at this point. Will be an anticipated loss.
8. PUDFA date in May, and Dalb will be approved. Fully anticipated already and discounted.
9. All time highs mean nothing unless you sold...Ditto with all time lows... LOL!
10. Not sure about EU submission before the end of 2014 but probably highly likely.
11. Quite a few firms have had buys on the stock for quite some time. Price targets were recently raised.
12. Zyvox is a Pfizer drug. Tedlizoid was owned by Trius and acquired by Cubist. Competition in the space is starting to get very crowded IMHO, and some lead antibiotics are going generic next year, or the year after.
DRTX will need to sell our drug on price and benefits.
Ironically, Ebola was one indication for ST-246/247 that the company felt could be developed via their pipeline.
They may have even started preliminary studies on the feasibility of pursuing it. Maybe even received some modest grant money to pursue it. Then...nothing.
Not only would that had been a big money maker today given the outbreak and spread of Ebola in Africa,
but the PR and goodwill for the company would have been worth it's weight in gold. To dream the dreams of what could have been if only, etc. etc. ... What a shame.
Siana....Definitely not beginning. A lot of bios down 30%-60% off their highs within a few weeks so it's been brutal. I have the deep scars to prove it too!
Do not feel it is over yet either. I think we might see a little more rally in the group then they'll hit it hard again and drive out the rest of those buying on the dips thinking the bloodbath is "over". But once that is over the rebuilding phase will take it's place and that could go on for months. A lot of damage has been done technically in the last few weeks, and they'll be a lot of people trying to get out of their positions as the stocks move up. Perhaps by the end of summer the damage will be repaired and normal order resumed, but that's only a guess. Nobody said it was easy did they? LOL!
stock_lurker.... Good post and well reasoned. I've been in bios for 25 years starting with the mother of all bios...Genentech. Your thoughts are right on. Been involved is some good buyouts, the last being TSRX by CBST last year for around $16. Was in that name large from the 4's.
In the antibiotic space a lot of competition is coming aboard. Not only the new companies like TSRX and DRTX, but generic competition as well. Pricing will be key going forward. The differences between choosing one over the other primarily money. If Dalb can be cost competitive, plus save the hospitals a patient lying around in a hospital room for a week receiving antibiotics, (when they could do it once a week on an out patient basis) such is a big advantage for DRTX.
Going it alone I would hate, and would probably sell on that news. Saw what that did to AMRN, and I have no desire to live through that nightmare again with DRTX. You have to have a very large sales force behind your product, PLUS, the ability to bundle it with other drugs to come out on top. Trying to undercut a CBST purely on price is going to be a loser IMHO. And the costs and dilution to current shareholders in starting up a large sales force, and mfg and distribution, would be substantial. No thanks.
I frankly foresee a buyout of DRTX in the high teens within six months following approval.
At least that is what my personal Tara cards read...LOL! GL to you and all longs!
Good for you Minnie....I thought long and hard re IDRA and have been in that situation before and fought the urge to hold it after the brief rally from the psorarsis results. Glad I sold but you did better than I on your first batch of sales in the mid 5's... Nice.
You want a small spec biotech that "could be" huge. Read up on RXII. I own it large from around $3.50.
RNAi company with a guru CEO that was one of the major discovers of RNAi. Using their first product to treat surgical scarring. 43% reduction from placebo in Phase 1 trials and no known safety or usuage issues.
Could be a 5 billion dollar worldwide market. Read up on it and let me know your thoughts. Their product is not a delivery system like ALNY or TKMR etc. The drug and the delivery are one and the same using
RXII technology, so it can be systemically potentially used for any number of drugs and treatments, aka
No...the results were very good in the Phase 1 as far as it went and the drug seemed well tolerated as well.
I'm just very skeptical of Phase 1 results, as the trial sample is usually very small, and the patients are sometimes cherry picked, etc. The Phase 2 (or 1a whatever they may call it) will be much more telling
as we'll see the entire spectrum of increased patients; side effects; and effects of varying dosages etc.
If they can repeat the Phase 1 results, or do even better, in a much larger sample size, then we could well
have a huge winner here. I mean a 47% reduction is scarring from the use of a topical cream (or other non invasive application), would become state of the art following surgery very quickly. A huge market potential.
Thanks, but Phase 1 data is almost totally irrelevant unless the drug is flat out toxic. And terms like "dose dependent effects" sound like the release from IDRA after their early psorarsis trial showed lousy efficacy,
but claimed "activity" and "proof of concept".
This proof of concept stuff by some companies is plain BS. In our trial the drug, as delivered, will either show substantial reduced scarring over the norm or non treated group, or it will not. No way to ginger bread that when the results are released. Fingers crossed, and very long.
Hope you bailed on that one. You know I sold at $4.80 and you were kinda critical of that, but
it's not the "real deal" IMHO. Once a drug, or platform, fails the earliest indicated trial for whatever reasons
the company, or message "posters" may tell you, get the heck out. Can't think of an exception. In bios
sometimes your first loss, is your best loss. DRTX will recoup it for yah though!
The nut job(s) here are having a nervous breakdown creating new IDs just about every day and are now copying and posting old posts from either me or Drod on unrelated Siga topics. The person or persons are truly nuts. Mental health is a very serious issue in the US and this Board proves it beyond a doubt. Some here need to be in locked wards...Seriously.
Ymeddyliwr.... First...you need to calm down, relax, and restore brain order. Your anxiety is what those selling short are attempting to cause, so don't play into their hands.
There is nothing wrong whatsoever with DRTX...the company. A secondary offering at some point in time is not "bad". If done at the right price it could be very "good" for the company and its shareholders.
Label restrictions? Definitely . Was already mentioned during the panel meeting. The label will state it is not for pediatric use. It will state it is not for pregnant women. It will state that if you have liver issues you should consult with your physician before taking; The FDA may well require post trial studies involving liver issues.
Black box warning? Are you serious? When did the drug last kill someone? Come on man...read up on what you own...Seriously. Delay of approval? No way. Vote was unanimous to approve by the panel. What would the delay be for? You're starting to sound a bit paranoid frankly.
Have you bothered to look at how the other antibiotic stocks have been trading of late.
TTPH....$17.7 to $9.02
CEMP.... $15.39 to $8.85
AKAO.....$21.25 to $13.30
CBST......$82 to $61.66
Not sure why you would have invested heaving "over time"..."over the years" and ridden out the uncertain times, and now are on the verge of panic just before FDA approval, and a very bright future for the company? That to me is more perplexing than how the stock has performed of late. May I respectfully
suggest that once order is restored and this stock regains its former glory days and you ultimately sell,
that you swear of biotech investing for the remainder of your days! Seriously.
Anybody here still think that the psoriasis trial results had no effect on the recent drop in the share price by 50% from just a few weeks ago? Just wondering.
Craigbarnard... First of all...welcome to the Board.. I have been in this name large since 7. TSRX before that from $4 and it was acquired by CBST for $15 plus...Also own TTPH, CEMP and AKAO in the antibiotic space.
Your post was somewhat confusing frankly. The May 26th PDUFA is all but a formality. The drug already went through FDA panel vote just a few weeks ago with unanimous recommendation to approve. The stock did not rally much on that news, and will not rally much on final FDA approval because that is already assumed. Phase 2 results were a few years ago. I believe you are referring to FDA approval after a Phase 3 is successfully completed. That's a done deal. Only issues before the final FDA committee vote is labeling, and post approval trials. Effectiveness and dosage was already established in the Phase 2 and 3 trials and there is no issue with that either.
This company is not typical. This is no screaming #$%$ shoot pie in the sky cancer or Hep "C" drug. This is a real company with much needed once per week IV induced antibiotic to treat gram positive bacterial infections. IMHO only it is a likely acquisition target, much like TSRX was. Four firms have $18-$20 price targets on it. Just wondering where you might have come upon DRTX?.
Institutions missed on TSRX and will miss on DRTX. Too small of float for them to get involved. This is a retail play for the smart folks, and there aren't a lot of them out there frankly. The stock is worth $18-$22 so at $12 plus, with FDA approval a given, and a 400 million potential market for dalba, the risk reward heavily favors buying now IMHO.
Yes...If only Siga made a smallpox vaccine that would be really relevant. But unfortunately they make
a smallpox antiviral for the limited folks who can't take a vaccine.....
Think most conservative estimates for dalbavancin are in the 400 mil range. Bought more today at
$12.58 and I already own a ton from $7....
Think if you're patient and don't expect $18-$20 within a few months, you will do very well buying at these levels.... You have at least four major firms who think this is a $20 stock. It is. IMHO!!
PIP.... Yes...I called that one exactly right by the way. You can go back years and read all my posts on the subject. My thesis was that Pip would win the lawsuit against Siga. No doubt about it. And I was dead right.
Problem was the markets perceived winning 50% of St-246 wasn't worth much, and Pip stock basically went down after the verdict. I bought Siga big when the Barda contracts were confirmed and the company was looking at 3 billion plus in revenues for the contract, plus options. Paid as high as $15 for this POS. Then CMRX challenged the contract and Siga said no big deal and they were taking the "high ground" in the dispute. Few months later the option part of the Barda contract was gonzo by BARDA, thanks to good attorneys for CMRX, and our high ground approach to the dispute.. Before that Rose and his gang were selling millions of dollars worth of stock as soon as the ink dried on their certificates. They dumped while I was buying more. In fact, I probably was buying their stock...LOL!. Next came the legistlative actions that the contracts were basically given as a favor to Siga based on conflicts of interest. Reps Issa and Sen. McCaskill. Stock tanked to $5-$6. I got out. Huge loss for me. Made it all back in the following years on bios that I bought and posted here. TSRX from $4 to $16 in a buyout by CBST. Many others as well.
End of my story. And yours? LOL!
LOL...Maybe yah think someone knew this research report might be coming out? Oh well...the poor guy
or gal ended up just breaking even, or holding the bag for now too! "A" for effort I guess!