Exactly who would pay someone to baxh this POS? LOL. What a waste of money that would be. Screening halted months without any explanation, lawsuit by biggest sharelholder, money spent like a drunk sailor on a related company without known results, a trial lasting nearly a decade, no results from a trial with matched controls after all this time... No self=respecting paid basher would take the job.
You seem reasonable other than your statement that we should ignore the negatives. Why should we? I am long but I see no reason to be overoptimistic. The committee even downplayed their prior approval of Pro. They see danger in the implant itself. I don't agree with them, but for whatever reason they seem pretty negative.
Humans being equivalent is a negative since sublingual is much better able to cope with that situation then is an implant which does not have regular frequent appointments to adjust the medication. In fact the committee considers rescue to be a specific failure of the implant. Why have an implant if you have to adjust medication with any frequency. Blacklist specifically saying that I rescue medication would be considered a failure for the implant. As for missing urines look yourself at the specific analysis the committee performed and their conclusions
frank has the same right to post as you and makes a lot more sense. Did you ever consider that the facts as far as we know them are totally against the company.
It is not encouraging, especially the reanalyis of the data assuming urines missing are positive and the discussion of rescue medication and its role in determination of success. The committee believes evidence of efficacy is tenuous and may not translate to the real world
Take the FDA's statement that Pro should be better than SL because compliance is guaranteed. That begs the question, since that is part of the rationale of Pro. The result is the endpoint. That's what counts. Last time they used the same flawed logic. They said Pro could simple be preventing withdrawal not providing treatment. Who cares? It worked, it met the endpoint. One can always argue about the mechanism. They are not following the rhe rule of empirical drug research. They are not objective and are not to be trusted, and they can conclude anything they want. I want Braeburn to fight them if Pro is rejected.
this only pertains to 'rems' not to study results, which were marred by infrequent and missing urines and the issue of rescue medication. This does not mean we will be rejected, but it is not a slam dunk like we expected. Any study can be criticized. The notion that the results should be superior because of compliance is a low blow, just like there were low blows last time. I never said this before, but the FDA is not playing straight with titan. I distrust them and suspect money is at work.
Not too much really. Psdv was already pretty secure supply source. My hope is alim gets to distribute illuvien in Europe at least, maybe everywhere or whoever buys alim gets to do it. I hope they are sold, bottom line.
I read the document and did not find this conclusion. Tell me what page it is on. I highly doubt they would state a conclusion that baldly and without qualification. It sound nothing like their skeptical language.
and you should be at the racetrack or the roulette wheel. It would be more of a 'calculated' gamble and less of a fool's errand.
Sounds good. GLTA. Things look good, if we get a little cooperation from the market. ALIM is undervalued too but I'm afraid it will have to do a desperate financing before it runs out of money. I hope they sell it. and am surprised there are no indications of interest reflected in the stock price so far.
You are an angry person . you cannot handle opinions different than yours. If it matters at all, I am in Naples Florida for 4 months ofl the winter and overlook Gulf of Mexico.. Does that make me a smart as you are?