The current price of BIOD is factoring in no chance of approval at month end. Just a CRL of differing difficulties (new trial, no new trial, manufacturing issues, etc.). However, BIOD did this filing the right way. They got all the answers and did all the reformulations and answered anticipated FDA questions BEFORE filing. The FDA doesn't like asking for the answers to big issues after the NDA is filed. Provide them with the information upon filing except for normal review stuff. The only question is will the FDA accept the answers on India or not. I think it is 50/50 chance. If they do and this is approved then we are looking at a stock over $20/share. If not, and the FDA makes them do another trial, then maybe we drop $1 from this level as a negative response is already factored in. Plus all the unknowns become known and the stock will do nothing but climb from there. Thus, it is ridiculous to sell at this point with that risk/reward equation. It even makes sense to buy 1/2 a position here and buy the other 1/2 if it hits the 2's. I think the FDA response could go either way, but the mkt opportunity says buy some now. If you disagree, fine, but my guess is you haven't done as much due diligence as me (did anyone else go to the ADA conference in June and meet with mgmt like I did?). This is how I have played this stock and I paid higher then today's price.
very well said blod-factma!!! the reward is so unbelievable favor over the risk(at this level) so i truly start to believe that some strong interest group manipulating the public perception and gobble lots of shares at dirt cheap price. i am not a pumper and
never post in here but at this junction i couldn't
help it- this is once in a life time opportunity to
do very well with so little risk regardless the out come of FDA
As the PPS suggests, most people are betting it will get a CRL this time. But they are all looking to buy down low if this is the case. Your gamble here is you will lose that opportunity if there is a "surprise" approval. The price you will pay if there is a CRL is likely a 50% haircut.
I don't think even a 50% haircut if there is a CRL. Factman,did you do diligence on their manufacturing facilities? I think one of them might have had a problem in the past. I have no expertise in this area. But I do know about diabetes treatment, and to have a SQ injection of a well known molecule in a slightly different formulation is highly likely to be safe. I also know that it would be a huge advance to clinical treatment, as I have outlined before (prandial insulin injections, short term glycemic corrections, insulin pumps, and eventually closed loop insulin pumps). I think the FDA really cares about what improves medical care for patients, and in my opinion, this is it!
I see you are keeping notes on my holdings biotechinvestman. And I'm no godfather. Just try to do my homework and know my risks and pass along some info to help others on this one since I've done a fair amount of due diligence. Risk here is time and maybe a little downside, but end result is pretty certain. I have been avoiding the board some lately b/c of non useful posts.
I think Errol de Souza was the right choice for CEO. He has the connections for a partnership and has executed this exact scenario before several times and doesn't overpromise. Not arrogant either which I see too much of and usually hurts companies like this in the end in partnership talks. Krasner is fine for his job and very friendly. It is good to put Sol Steiner back in the lab as he shouldn't be CEO at this point and is too quirky I think to lead. He is an old Jewish guy that is a little bit a hypster, but a smart scientist nonetheless. Gerard Michel is fine as far as personable and I think a good communicator to investors, but he is a little bit of a nervous nellie. All in all, I would rate the mgmt team pretty high and think they have the talent to get this approved eventually and capitalize on the rest of the pipeline (which could be extremely valuable).