kiddo, you are "kidding" yourself and delusional if you think SOLI is a blockbuster abx of our time. It is simply a me-too drug undergoing NI studies....it's an analog of erythromycin with comparable or slightly better in vitro activity, which does not show superiority in clinical setting. I am not saying that it doesn't work but the fact of the matter is that many other antiobiotics work just as well in clinic, and uptake will be driven by cost.
kitty, again you disappoint me and showing your inexperience....deadly for investing in biotech, LOL! The trial is not designed nor power to show any differences against C. Diff. Trust that all fairly broad abx can induce C.Diff....
some pretty lofty statements there buddy...whoever said I invested in DRRX? I am a Short and Long investor and can spot extreme valuations from either side, thus this has made me very successful. If you were referring to PTIE, I am invested in PTIE as this is an extremely undervalued biotech with a valuable completed P3 asset unlike the ridiculous valuation for CEMP based on false premises for potential commercial potential of SOLI......You will crash and burn if you stick too long with this one.
md, your statement is simply not true and you should be ashamed for pumping this info. It does NOT work on all g-, especially the signicant g- (like psuedomonas, acinetobacter, etc), this class of abx can't cross cell wall. It works may gonho just as other macrolides/ketolides work on gonho, but special case just like H. influ.
First of all, MOXI is NOT the gold standard in terms of treatment options. As there are many different bacteria (both g- and g+) that can cause CAPB. Various strains vary in susceptibility but clinical outcomes are generally predicted by antibiotic concentration levels (PK/PD) and can be empirically tuned to optimize treatment. The nice thing about quinolones and beta-lactams is that they are active against both g- and g+, so empirically it would be sure to hit ALL. Note that macrolides including Soli only are effective against g+ with exception of H. influen (fact). Thus your standard one of the many dozen macrolide, quinolones, beta-lactams, or aminoglycosies could work.....take your pick!! Again resistance is NOT clinically relevant..if it were you would be seeing siginificant treatment failures (which is not happening)!!!
the reason they developed IV is to use as pseudo marketing ploy since they know they won't have much advantage with another me-too antibiotic. Cost for the payers is going to drive update, and believe there are plenty of options to treat CABP with identical effficacy at generic price point.
Based on your lack of knowledge regarding C. Diff infection, you don't have much cred in my book. And you really should take a deeper look #$%$ deals that TSRX and OPTR did as their pps was in the dumpster (particularly OPTR due to #$%$ sales after almost 2 years launch). Luckily for CBST they had their one decent drug....totally different indication.
I guess I will need to continue to educate Longs...in vitro resistance rates (which you are quoting) DO NOT correspond to clinical resistance rates (just the facts). Most antibiotic work fine to treat CAPB in the clinic!!!
HUH??? Kitty, you disappoint me. You do realize many broad spectrum antibiotics have activity against C. Diff. You need to better understand the epidemiology of C.Diff infection before "spouting off"....LOL! Just because you may kill C.Diff doesn't mean it prevents re-infection after killling off normal flora. Jeez, where did you get your PHD??
First of all, let's get some things straight. I was attacked first (review the posts), thus I respond heavily when attacked by bullies especially the message board bully types, trying to police message boards. You have to admit I am raising very solid contrarian opinions on this board (to many pumping longs dismay). I am not saying SOLI is a waste of time, I actually think is a ok or me-too drug. The problem I have is with CEMP's valuation, completely ridiculous. And YES, I am a Pharma expert and have seen these types of companies come and go with this type of hype, especiall after they launch and can only sell at most $50M..stock crashes!! If SOLI was a significant improvement, trust big Pharma would be all over this....
Jeez, now folks are starting to wake up and smell the $%$# that CEMP is dishing out. I am glad I spoke up and folks are now starting to question and do some real due-diligence and not rely on hype of resistance. I deserve some props for this don't you think, LOL! The truth of the matter is Soli is a broad spectrum antibiotic and will also cause C. Diff (no question). From a clinical perspective all of the above antibitiocs will have similar positive treatment outcomes (no question). The BB warning on quinolones for tendons tox is idiopathic and considered very low risk as it wasn't never identified in large P3 clinical trials, and is still used. Other antibiotics and classes (including generics) are heavily prescribed for CAPB. That leaves the main QUESTION, what is Soli's advantage to help gain all this blockbuster market share that pumpers are making you believe????
significantly less competiton for those indications and large need for MRSA treatment paradigms and IP is strong, thus the nPV is significantly more attractive. Sorry Taksta (generic fusidic acid) does not cut it!! Soli does not work in those indications (not active against MRSA)!!
Folks, don't be fools. The reason Big Pharma has not swooped in is because they KNOW the nPV on this and commercial potential within the current payer environment....this is complete hype and your being conned big time!!!
blockbuster status based on non-inferiority and soooo many antiobiotic treatments out there....unbelievable!!
Suggest you do some real boy home work on this and take a look at all the antibiotics approved for CAPB...macrolides, quinlones, beta-lactams, several other classes, etc, etc. Most are already generic, safe, and work quite well!
Does every one on this board actually think that Cempra's pipeline is in anyway differentiating from the standard of care. Sorry, non-inferiority studies don't cut it from a payer perspective! There are way to many antiobiotics to choose from and why would a payer decide on this new expensive drug vs. a generic when cost will be significantly different and they work the same (even the data will point to non-inferiority!) And "resistance" discussion is way overblown. There are few clinically relevant resistance in CABP!!!