Paul, you do realize that the longer this delay occurs the more likely the company will need to raise more funds. Also, the likelihood of competitors getting to market with their products first. Just saying, there is a reason this stock is heavily shorted.
Wow, some writer took the time to analyze MCZ inside and out. There's no possible way a computer generated those paragraphs. No way.
You said before you were "ALL IN" but now are adding more shares? Guess it is time to have a garage sale or take out a loan!
You were blindsided. I don't think many people expected this outcome of a CRL. The good news is that the problems are all out there and they seem minor. Have you considered adding to your position here?
ACRX will likely have their product approved, I agree with you. But, I think many shorts aren't concerned about that...they believe the product is going to be a tough sell in the marketplace. Honestly, I don't know how successful this product will be when approved; all I know is that they will need to sell a lot to be profitable, so it will take at least a year (probably two) to get to profitability. I'll play this as a trade and sell on approval.
But the news about the CRL is already out. I think the halt should be lifted before this even starts trading. It is also rare for a halt to persist through a conference call and be lifted BECAUSE the CC is finished. So, trade away on this all day!
The guy seems really smart to me. I doubt anyone can get all this stuff correct. He wasn't alone in predicting approval. It seems everyone thought so.
I'm just curious, if you don't think he is very credible, then who do you think is a good source for biotech investing? I think Adam F. has some of the best *free* investing advice I see out there.
If you think this will take a day or two for Acel to fix, you're crazy. Acel will try to make sure that the FDA gets exactly what they want, and this will take months to work out. Sorry, I realized you got caught with your pants down on the CRL news, but everything will probably work out for Acel in the end...it will just take much longer than you thought.
Sorry, but these things always take longer than optimistic shareholders think they will. I would bet you a cool grand that this approval will take much longer than February of next year. The market (or agencies) aren't going to satisfy your every whim. Were you thinking the FDA would approve Zalviso today? I rest my case, sir.
Interesting, I was assuming a longer review. Maybe they will say on the conference call on Monday what class they anticipate falling under.
I've made the mistake before of buying in size and thinking I knew for sure what was going to happen. Taught me humility. Good plan you have. There will be some panic Monday, I'm guessing. It will be a good time to make another buy, but wait until all the impatients are washed out in the weeks ahead before going all in. That conference call is going to be a key factor in how the stock trades Monday.
Yes, this does fit with my estimate too. Submit in December and review occurs in September of next year, likely.
It's hard to say 'cuz were really don't know anything right now. But, yes, a financing raise is possible now.
Doesn't it have to go through the PDUFA process again? So, reviewed around August or September of next year? Launch may actually be Q1 of 2016. I hope this company won't need to do a cash raise.