“I was right about predicting FDA fast-tracking and probably...

“I was right about predicting FDA fast-tracking and probably taking note of the developments in Japan”.

Let’s look at this carefully. Oh, but there I go again, being “technical and reductionist”!

The FDA have a process for Fast Tracking of products, and it’s applied, at a company’s request, to products which meet certain criteria: serious disease, serious unmet medical need, and similar. It is true that certain stem cell products have been granted Fast Track status: Osiris/MSB’s Prochymal and Brainstorm’s product for ALS. What is, I think notable, in the context of what passes for discussion on this forum, is that:

It is misleading to imply that the FDA is fast-tracking stem cells as a group. They fast track specific products, that fit a particular niche. Many other conventional pharmaceuticals are also fast-tracked, if they fit the criteria.

If they did it in response to the Japanese proposals, they would have needed a crystal ball, since the Osiris fast-tracking occurred many years ago.

The source of Dolcevita’s assertions in respect to the FDA fast-tracking stem cells has been questioned previously, by the redoubtable, if occasionally too long-winded for the casual reader, Madamswer. Dolcevita had previously referred to “…noises coming from sources in the US that the FDA is rethinking their processes re stem cell requirements”. Madamswer, not unreasonably, asked for a citation, but sadly, Dolcevita was unable to provide it, on account of an onerous examination workload, and an unfortunate laptop meltdown. Helpfully, Dolcevita advised Madamswer to “…go to the USA for commentary on the FDA”.

Interestingly, in the same post, he/she noted that “The FDA has a heightened sensed of caution around stem cells in general and non-autologous stem cells in particular, I assume due to…ethical controversies… using embryonic stem cells… and the fact that this is a pioneering area”. We are then reminded that MSB uses adult stem cells. So, perhaps a degree of ambiguity in Dolcevita’s position? Presumably his/her assumption that FDA's concern related to embryonic cells is what will dull the FDA's sense of caution in relation to MSBs cells. Me? I think the FDA will look dammed hard, just like they do with every other drug. Though, as I've noted previously, I doubt they will uncover any major toxicities.

The FDA are constantly reviewing guidelines on therapies, and stem cells are no exception. There are regular updates on guidelines relating to pre-clinical studies, manufacturing requirements, clinical studies and other aspects. It is entirely unremarkable that they should issue new guidelines relating to stem cell trials.

So, I’m personally unaware of any change of heart at the FDA that will expedite the study or approval of stem cell medications in general, outside of the more general mechanisms that are available for other products. However, I stand to be corrected, and actually, would be very pleased if such systems were in place.

I hope that this puts to rest any lingering concerns that you might have that I haven’t addressed your point about FDA fast-tracking. As for whether you are “right” – I will leave others to judge.

You also suggested that I hadn’t addressed your rather vague notions of momentum, sentiment and MSB being the world’s leader in stem cells. So here goes:

·Momentum: It’s an unhelpful phrase, but in general, yes I agree with you that MSB is making progress, and are at the vanguard of a new wave of medicine. They are securing grants, tax relief and all sorts of other goodies. All of this is, however, somewhat irrelevant until we see a successful Phase 3 study, which demonstrates, unequivocally that MSBs cells work in the target population.

·Sentiment: Seems to me that, relative to the heady $10/share days, sentiment is a bit on the nose.
(Cue diatribe on Macbank, shorters, dark forces, HC-based conspirators etc etc).

·World leader: In market capitalisation – absolutely. In number of clinical trials underway – certainly. In basic stem cell science – unlikely. In clinical trial design – no way of knowing. In prospects for success – no way of knowing.

So, does Dolcevita know what he or she is talking about with respect to FDA fast-tracking?

Joint the dots, people!