The deadline is 2020/2021... and the last part of your statement is just not true.
Well, it is interesting you say that, because that FDA approval can now actually allow for buyout negotiations... so was it priced in, or is it relatively low float manipulation (to take out stops)?
In fact, a friend of mine bought some shares on Friday and got stopped out along with a ton of other people at about 11:30 today.
Also, I have to ask, you mentioned a stock that was down 90% when the FDA said they wanted another trial (CRL?), and then the company submitted some data and then everything was good. Can you tell me the name of the company, please?
I just read through a bunch of your posts. I agree with a lot of what you say. I agree that Baker Brothers wants a buyout to start pouring money in their other investments. You mentioned you thought the buyout would be in April, but that hasn't happened.
There's been a drought in M&A this year that has only recently picked up. If not April, when? This month, this quarter, this year? What's your current opinion on timing?
I think that this review team would not even be against off-label use. However, more money will be made once more indications are proven.
I mean, if they just had a placebo injection and octreotide pill vs. an octreotide injection and placebo pill they would know. The octreotide injection is not stable since the effect decreases slowly and then rapidly towards the end of the month. I don't see how it could be double blind because the patients would absolutely know whether they were taking a placebo injection or placebo pill.
It would also the muddy quality of life assessment which is the critical factor in differentiation.
It's not so simple. You missed the first sentence:
"Upon completion of its review, the FDA advised Chiasma that the Agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval, and advised Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency."
However, I believe that they can still overcome this issue, and possibly appeal the decision in a hearing, because the data to me seems incontrovertible proof of efficacy of TPE technology. I believe they could get a partnership as well, even with the CRL. Plenty of companies need this sort of technology.
Finally, just a quip, but "double-blind" does not mean "placebo-controlled". However, I still think double-blind is unethical because they'd be requiring subjects to either overdose or to dose with multiple injections towards the end of the month (when the once-monthly injection starts wearing off), which starts hitting an ethics issue rather quickly.