FDA DecisionI'm not surprised that FDA is requesting more data and another phase 3 trial from Lykos, through they certainly could have collected more data with an approval and added restrictions too. What this does in my opinion is allow big pharma to get into the game, which it smells like big pharma may have had their fingers all over this FDA decision. Because these trials were not done by big pharma, I believe the FDA is having a hard time accepting the data even though the results look solid. I think the FDA want and prefer clinical trials conducted by big pharma.
It is my understanding that if this application was successful Lykos would get about 5 years of exclusive US market access as the supplier of MDMA. So this is why the FDA decision or the panal's decision should never have had any affect on Pharmala's business one way or the other as they don't do business in the US, nor would they have been able to supply any MDMA in the US market even if the FDA approved MDMA-AT. However, I think this decision can now open up business in the US for Pharmala as a supplier through increased clinical trials.
“As a result of this decision, we anticipate clinical research on MDMA to increase; PharmAla is an important supplier of MDMA for that research, with over a dozen human clinical trials contracted globally, and we will continue to support our partners in their efforts,”
One of the biggest concerns was the cardio issues with regular MDMA. Pharmala has a US patent MDMA derivative that significantly reduces the cardio issues.
“Our preclinical research, now published, has proven that we have significantly addressed these concerns. By addressing these safety issues, we believe that PharmAla’s ALA-002 development program is exceptionally positioned to gain favourable approval by regulators.”
So if big pharma in the US is looking for an opportunity to jump into a phase 2 clincial trial with a better MDMA drug that is more likely to get FDA approval, then Pharmala's ALA-002 is clearly an option. This would allow that pharmaceutical company to likely be the main supplier of MDMA for therapeutic use, not just in the US, but around the world. As Pharmala is already building a business outside the US I think this makes them a prime candidate for a partnership or an eventual buyout for their IP. I'm sure big pharma must realize that MDMA-AT is inevitable and if they want a piece of the pie, now is the opportunity to jump in and get the phase 2 clinical trial started on ALA-002.
So if I am correct, the non-approval by the FDA now allows Pharmala to freely access the US market and extend and expand MDMA supply into the US for clinical trials (i.e. increase revenue), which they would not have been able to do on an FDA approval. So hopefully we start to see some news flow on that immediately. In the meantime, ALA-002 can move through the clinical trial stages for a more likely approval by the FDA, if or when Nick can get a deal inked with a partner.
So as I see it, the key for this company is the ALA-002 clincal trials because even if Lykos were to eventually get an FDA approval in the future on their MDMA with cardio warnings and get 5 years exclusivity in the US of supplying MDMA, the approval of ALA-002 would be able to break through that US exclusivity as the MDMA derivative would be considered a new type of MDMA drug. So if big pharma or even a billionaire decided to jump in on a deal with pharmala to conduct phase 2 & 3 clinical trials with ALA-002, this would bring them into the game with what looks to be the better product.
Way too much emphasis was put on the FDA approval for a company that doesn't do business in the US. Yes, FDA approval would have opened up the need for a greater supply of MDMA in the US, but Pharmala would not have had access to that market anyways. Now Pharmala will have access in the US market for more clinical trials, as Lykos doesn't get MDMA exclusivity to supply! And Yes, the FDA approval tends to be somewhat of a gold standard around the world for drug consideration in some other countries, but this is not always the case. There are many drugs approved in Europe, Canada and many other countries that are not approved in the US by the FDA. The FDA doesn't always get it right and in the US lobbyist can often play a major role in the approval of a new drug. And besides, given the data that has already come out on MDMA-AT and its success, do you really think other countries are not going to continue their clinical trials or approve MDMA-AT?
Far more doors should be opening for Pharmala then closing. Like I mentioned, I would expect some news releases from the company of those doors opening and deals being inked. The FDA decision may have been holding up some of those deals. So let's get this show on the road Nick, Pharmala has trials to supply and lives to save!
One other thing. If the FDA had approved the regular form of MDMA with all its side effects and just given it a warning label to proceed, then I would think Pharmala's ALA-002 becomes less important in the eyes of big pharma. Big pharma may not care about a better form of MDMA if they can simply slap a warning label on the current form of MDMA. So with the FDA's concerns of the racemic MDMA side effects, the importance of a MDMA derivative without the side effects becomes way more important to produce for FDA approval. Think about that!!! In the end, this may be the best news for Pharmala in inking a phase 2 clinical trial for ALA-002 and the FDA decision may have been holding up a deal. (?)