I've been following this company for a few months now as they seem to have an interesting pipeline, but in 35+ years of practicing medicine I've never seen a more misleading press release.
"Safe and effective" cannot be declared from an open label phase 2a study of 22 patients, of whom 6 apparently dropped out. It would be assumed that these 6 dropped out because of lack of response. Efficacy in a 5 week study is meaningless for a chronic disease. And what if a significant adverse event occurs in 1 of 500 or 1 of 1000 patients treated, a probable deal-killer in terms of FDA approval. A small study like this says nothing about safety.
Declarations like those given in the press release give ammo to the lawyers to sue them for false and misleading statements if the drug flops, and make management's credibility questionable.
You may be a doctor, but are surely not very knowledgable about clinical trials activity. I have 35 years in regulatory affairs; have set up and reviewed many clinical trials from concept to launch. Please get your information correct before posting. Small investors like me who are not knowledgable about this area may buy or sell based on your comments. And this is not fair to them!!!
Proof of concept studies are typically Phase II studies and are performed in a small number of subjects and in this case the subjects are patients with the disease. Proof of concept often include several doses and are used to establish the dose and patient population to be used in the subsequent confirmatory Phase III studies.
The idea is not to burn a lot of cash on a large trial without first knowing if the drug shows any efficacy or has safety issues, thus the small population.
Keep watching, deep pipeline and BLRX always manages to get cash and financing through licensing agreements rather than dilution or loans.
BLRX business model does early stage testing and goal is to entice a partner to take it further. As such, they don't burn through a lot of cash the way other small biotechs do. Hence less dilution. If a partnership is struck with a big pharma, I would expect the terms to be not as good, since the drug would be early stage. They do have interesting drug candidates and a small market cap. This is a speculative stock, -personally I like some of their candidates -esp. the allergy drug in very early stages of development. If you don't want to speculate, then you should not invest in this company. If you want to speculate but don't believe this company has a shot at achieving anything, then don't invest in it. It's not that complicated, Dr. I read that doctors are poor investors -perhaps, and I'm not saying this meanly - but perhaps you should hire professional financial advisor and stick to practicing medicine. Leave the investing to professionals...GLTA
Well well well, lookie here we have a "Dr." with 35 years of practice experience LOL and he is upset with everything today.
I am sorry that this unexpected announcement is screwing up your short position "Dr." but this is simply a small warm up because if they announce great results for the cancer drug up we go 50%-100% and don't forget about the ole hepatitis drug which results should be within a few months in fact many catalysts over the next 6 months will leave you and your short buds penniless.