Tilator, It depends what you are referring too. I have been investing in pharma stocks for just about 40 years now. so I am very familiar with all the aspects of the industry. I also personally worked in the business sector in the legal profession working directly with the Federal Government for a large defense contractor. Not actually working with the FDA but the DoD, which when you work with one agency you tend to find out they all work the same. but with my legal background, I have a good understanding and comprehension of the Rules and regulations going along with the FDA. so, that is my background. So I feel confident that I can articulate my reasons for why I formed my opinions.
I have been invested in IPCI since 2012. I recall the original business model, which is why I invested in it. They were touting themselves as a technology company. one to formulate hard to manufacture drugs then partner them out. THAT is why I decided to invest. even with the lead scientist and founder being the CEO, which was a red flag. The business model made sense. You keep your costs and overhead low, you formulate drugs and partner them off, generating revenue thru profit sharing and licensing arrangements. while your profits are limited than if you manufacture yourself such as a stand alone company, your overhead is extremely low and therefore profit margin s much higher.
What happened here is Odidi changed the business model mid-stream without telling anyone. it just sort of happened. Rexista was to be partnered on 2014! At some point, Odidi changed his mind and decided to go it alone even further and now Rexista is suppose to be "plug and play" which means take it the entire way to approval before partnering.
The same thing happened with Regabatin, which has been shelved since 2015, again supposedly waiting on a partner. My guess is he is now waiting for funds from Rexista to go that alone as well, which is ridiculous. the value of Regabatin goes down as we inch closer to lyrica going generic in 2018. As well as Pfizer now having the first ER approved recently. that will give them market share plus the ability to hold IPCI up in court claiming they are patent infringing.
so the NDA pipeline is now all messed up. the ANDA is just as bad. generics are hotly competitive. look how big MNK is even with their network and the small percentage of the scripts they have taken so far with Seroquel. No way, IPCI should have undertaken getting into manufacturing as well. The company does not have the man power to effectively operate a manufacturing business when the CEO needs to micro manage everything. something else stalls, such as partnering the NDA !
we would be much further ahead had he stuck to the original business model. Rexista and Regabatin would have been partnered. he would have secured partners for the ANDA's and would have cash to be pursuing the next phase in his technology advance which is Podras. which if the only thing he had to work on was proof of concept he would have done by now as he would have had the cash and even that would have probably been licensed out and we would have had that already added to some other drug as an NDA-S !
so yes, in my opinion seeing the potential we could have had, I see working on manufacturing for generics as a complete waste of resources.
