LOl. At some point BIO will trade independently of oil, export companies,etc. Looks like today is the start. bio holding nice.
Guess you didn't see the Tues futures. Market is over sold. Bio IBB did a nice heavy wash out dive and bounce yesterday. Santa Rally coming. The correction is almost over.
Don't sweat it. Market is getting over sold now. I noticed huge jump in insider buying of the market. I was hoping to get some more under $11 but probably won't happen.
To be more specific…….The primary outcome analysis in both Phase 3 trials is non-inferiority in the early clinical response rates . Early clinical response rate is defined as improvement at 72 hours after the first dose of study drug, in at least two of the following four symptoms: cough, shortness of breath, chest pain and sputum production in the Intent-To-Treat (ITT) population. Soli should have no problem hitting the primary outcome as Soli is highly effective in all 4 pathogens. And Soli will blow Moxi away in secondary as this includes tolerability.
Im sure the FDA was well aware of the Z-PAK resistance . They couldn't go head to head. I think you have your facts wrong. S. Pneumoniae is the primary end point in the phase 111 and the main culprit in CABP and Soli kills it dead. The fact that Soli, a macrolide was comparable to LEVO in phase 11 was actually a huge surprise. Soli didn't have to be comparable to LEVO. Soli just needs to be effective in A-Typical CAP. Soli even works on STAFF which other macrolides don't. The study would have been stopped if there were no efficacy. That is why the pop in PPS with large volume on the news. As far as Moxifloxacin is concerned it will match Soli in test but it will have a lot of side effects in the study. It has black box on insert. That will hurt that arm of the study. The FDA is creaming their pants for a new Macrolide. And soli is it. Don't sweat it. Z-PAK NEEDS REPLACED!
yes... going up against Moxifloxacin. but, this doesn't matter moxi. is just a newer better fluoroquinolone. Also, the simple fact that Soli. doesn't seem to work as well with s. Pneumoniae compared to levo. could be a problem when trying to convince Soli. is better. Not to mention Soli. didn't seem do well when patients had Asthma and COPD comorbidities, however this data might be skewed by the fact that the Soli. group had about 10% more people with these comorbiditities then Levo. thus, possibly making levo look better. Anyway, i also having a hard time understanding why CEMP didn't compare with Zithromycin or telithromycin, the drugs its meant to replace. TSRX compared tedizolid with linezold. why not compare to the same class? something seems odd here...Unless moxi and Levo. are the preferred CABP treatments of choice...then it makes sense. Otherwise, it doesn't. maybe i'm just reading into it too much. I hope your right and soli. works.
i'm not pumping ttph and i completely agree that soli. could replace Zithro. i am just a little concerned about the CE data from the phase 2 and soli. didn't seem to work as well against S. pneumoniae compared with Levo. I agree that levi is very harsh, but if soli. doesn't work i.e. doesn't pass the noninferiorty test then soli. could go bye bye...im just saying.
um…..I think you are just pumping TTPH without knowing anything about Soli. Macrolides are the first choice in the community out patient setting with A-Typical indications. Fluoroquinolones are used in combination in hospital for respiratory, resistant, hard to treat cases. They are harsh on the body do to the killing of Bowel Flora which can cause C.Difficilea and eventual tendinitis problems not to mention severe diarrhea . It is pretty simple. …..Z-Pak was used 80% of the time in the community setting . It is 50% resistant now. Soli will replace it. Soli IV to oral step down could be icing on the cake in the hospital setting. And most likely Soli will be used in the community setting for gonorrhea as well. TTPH will be used for those that fail Soli. If TTPH gets bought first it is because a company can not afford CEMP.
i was checking out the CE Data that was in google...And it doesn't look good...soli. doesn't appear to be as effective on people in this analysis group. Levo. appears to do a better job. i know this data is only phase 2 but soli. looks inferior. check for yourself ...other opinions welcome.
You may be right, but I sold my position at $13.05 today. Looking at yesterday's action, too many sellers at $13 and the volume is waning today.