Replies to post #46343 on Biotech Values

[palindromy]

I would like to add one more takeaway since the DNDN story has still been financially rewarding personally -

When presented with battleground stocks, do not get attached. Trade, dont invest. Hedge, dont bet.

[rkrw]

Group Think should be number one.

I also wouldn't get too comfortable even if an spa is in place. SPA is nice but no guarantee...

IRVINE, Calif., May 4 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News), today announced it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for T-Pred(TM) (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension). T-Pred is being developed as a topical steroid to treat inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.

"While we are disappointed by the FDA's decision, ISTA is committed to bringing T-Pred to ophthalmologists and patients. We believe our clinical study met the endpoints that ISTA and the FDA agreed to in the Special Protocol Assessment," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Nonetheless, the FDA did not find sufficient clinical information to merit approval. We plan to work closely with the Agency to resolve this issue in an efficient manner. We intend to request a meeting with the Agency to come to agreement on the actions ISTA must undertake to receive marketing approval for T-Pred."

[masterlongevity]

great list Dew.

[mouton29]

I'd add a couple of others:

6. The Company has a great relationship with the FDA, they are in constant communication, the FDA encouraged them to file -- well, I recall Genta claimed a great relationship with the FDA. I want an example of a company that acknowledges a crappy relationship with the FDA

7. The Company is hiring lots of people, they must know what they are doing. Well, people who are hired can be fired, and companies take lots of risks -- if they didn't, they would not make any money if things go well.

[ghmm]

In addition to Dew’s warnings on Biotech investing (points 1 and 5 are my favorite) one other thing that really made me wonder was it appeared the DNDN wasn’t ready to go with Provenge even if they got approval. I am not sure how common it is but if you have a great drug with Block-buster potential, not to mention some potential competitors with similar technology a couple years down the road wouldn’t you be ready for launch within lets say a month or two of approval? They seemed like they were no were close and the manufacturing/CMC issues noted by the FDA add support to that.

I am curious if people on this board think Provenge will ever make it to market or is the survival advantage too questionable?